C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone

ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 DELUXE SAMPLEKIT- homosalate, octisalate, zinc oxide Jafra cosmetics InternationalDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they maybe marketed if they comply with applicable regulations and policies. FDA has notevaluated whether this product complies.

----------Always Foundation Makeup Broad Spectrum SPF 15 Deluxe Sample KitActive IngredientsHomosalate 4.25% Purpose SunscreenOctisalate 4.75% Purpose SunscreenZinc Oxide 7.0% Purpose SunscreenUsesHelps prevent sunburnIf used as directed with other sun protection measures (see Directions), decreases therisk of skin cancer and early skin aging caused by the sunKeep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.Stop use and ask a doctor if rash occursWarningsFor external use onlyDo not use on damaged or broken skinStop use and ask a doctor if rash occursWhen using this product keep out of eyes. Rinse with water to remove.DirectionsApply liberally 15 minutes before sun exposureUse a water resistant sunscreen if swimming or sweatingReapply at least every 2 hoursChildren under 6 months: Ask a doctorSun Protection Measures. Spending time in the sun increases your risk of skincancer and early skin aging. To decrease this risk, regularly use a sunscreen with aBroad Spectrum SPF of 15 or higher and other sun protection measures including:Limit time in the sun, especially from 10 a.m. – 2 p.m.Wear long-sleeve shirts, pants, hats, and sunglassesInactive Ingredients

C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone, Dimethicone, DimethiconeCrosspolymer, Ethylhexylglycerin, Glycerin, Hexylene Glycol, HydroxypropylcocoatePEG-8 Dimethicone, Iron Oxides/CI 77491/CI 77492/CI 77499, Kaolin, Lecithin,Methicone, Phenoxyethanol, Phenyl Trimethicone, Propylene carbonate, Silica, SilicaDimethyl Silylate, Sodium Chloride, Stoddard solvent, Titanium Dioxide/CI 77891,Triethoxycaprylysilane, Water/AquaProtect this product from excessive heat and direct sunJAFRA beautyalwaysFoundation Makeup Broad Spectrum SPF 15 Deluxe Sample Kit10 testers at 7.5 ml .25 FL OZ (US) eachTotal Contents 75 ml 2.53 FL OZ (US)

ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 DELUXESAMPLE KIT homosalate, octisalate, zinc oxide kit

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:68828-432

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:68828-432-

011 in 1 KIT; Type 0: Not a CombinationProduct 08/21/2020

Quantity of PartsPart # Package Quantity Total Product QuantityPart 1 1 TUBE 7.5 mL in 75 Part 2 1 TUBE 7.5 mL in 75 Part 3 1 TUBE 7.5 mL in 75 Part 4 1 TUBE 7.5 mL in 75 Part 5 1 TUBE 7.5 mL in 75 Part 6 1 TUBE 7.5 mL in 75 Part 7 1 TUBE 7.5 mL in 75 Part 8 1 TUBE 7.5 mL in 75 Part 9 1 TUBE 7.5 mL in 75 Part 10 1 TUBE 7.5 mL in 75

Part 1 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 SOFTIVORY homosalate, octisalate, zinc oxide cream

Product InformationItem Code (Source) NDC:68828-433

Route of Administration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mLZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL

Inactive IngredientsIngredient Name Strength

WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R)

TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)


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433-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

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OTC monograph final part352 08/21/2020

Part 2 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15NATURAL TAN homosalate, octisalate, zinc oxide cream

Product Information

Item Code (Source) NDC:68828-434





WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)



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Part 3 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15GOLDEN TAN homosalate, octisalate, zinc oxide cream






HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX)


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Part 4 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 COCOA homosalate, octisalate, zinc oxide cream







UF7620L1W6)ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX)


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Part 5 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 SHELL homosalate, octisalate, zinc oxide cream




HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL

ZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL





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Part 6 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 BUFF

homosalate, octisalate, zinc oxide cream







ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX)


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1 NDC:68828-438-01

7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package



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Part 7 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15NATURAL homosalate, octisalate, zinc oxide cream








WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX)


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Part 8 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 IVORY homosalate, octisalate, zinc oxide cream






WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O)

SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)



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Marketing StartDate

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Part 9 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15BISQUE homosalate, octisalate, zinc oxide cream









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Part 10 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15HONEY homosalate, octisalate, zinc oxide cream







ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X)

Jafra cosmetics International

GLYCERIN (UNII: PDC6A3C0OX)


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Labeler - Jafra cosmetics International (041676479)

EstablishmentName Address ID/FEI Business Operations

Jafra Manufacturing,S.A. de C.V. 814732061 manufacture(68828-432, 68828-433, 68828-434, 68828-435, 68828-436,

68828-437, 68828-438, 68828-439, 68828-440, 68828-441)

Revised: 4/2021

Documents

C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone