Label: ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 DELUXE SAMPLE KIT- homosalate, octisalate, zinc oxide kit
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NDC Code(s):
68828-716-01,
68828-717-01,
68828-718-01,
68828-719-01, view more68828-720-01, 68828-721-01, 68828-722-01, 68828-723-01, 68828-724-01, 68828-725-01, 68828-726-01
- Packager: Jafra Cosmetics International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 13, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months: Ask a doctor
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad 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 sunglasses
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Inactive Ingredients
C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone, Dimethicone, Dimethicone Crosspolymer, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxypropylcocoate PEG-8 Dimethicone, Iron Oxides/CI 77491/CI 77492/CI 77499, Kaolin, Lecithin, Methicone, Phenoxyethanol, Phenyl Trimethicone, Propylene Carbonate, Silica, Silica Dimethyl Silylate, Sodium Chloride, Stoddard Solvent, Titanium Dioxide/CI 77891, Triethoxycaprylysilane, Water/Aqua
- Other information
- Product label
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INGREDIENTS AND APPEARANCE
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 DELUXE SAMPLE KIT
homosalate, octisalate, zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-716 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-716-01 1 in 1 KIT; Type 0: Not a Combination Product 01/05/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 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 10 ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 GOLDEN TAN
homosalate, octisalate, zinc oxide liquidProduct Information Item Code (Source) NDC:68828-719 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-719-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/21/2020 Part 2 of 10 ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 COCOA
homosalate, octisalate, zinc oxide liquidProduct Information Item Code (Source) NDC:68828-720 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-720-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/21/2020 Part 3 of 10 ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 SHELL
homosalate, octisalate, zinc oxide liquidProduct Information Item Code (Source) NDC:68828-721 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7 g in 100 mL Inactive Ingredients Ingredient 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-721-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/21/2020 Part 4 of 10 ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 BUFF
homosalate, octisalate, zinc oxide liquidProduct Information Item Code (Source) NDC:68828-722 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-722-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/21/2020 Part 5 of 10 ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 NATURAL
homosalate, octisalate, zinc oxide liquidProduct Information Item Code (Source) NDC:68828-723 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-723-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/21/2020 Part 6 of 10 ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 IVORY
homosalate, octisalate, zinc oxide liquidProduct Information Item Code (Source) NDC:68828-724 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7 g in 100 mL Inactive Ingredients Ingredient 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-724-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/21/2020 Part 7 of 10 ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 BISQUE
homosalate, octisalate, zinc oxide liquidProduct Information Item Code (Source) NDC:68828-725 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7 g in 100 mL Inactive Ingredients Ingredient 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-725-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/21/2020 Part 8 of 10 ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 HONEY
homosalate, octisalate, zinc oxide liquidProduct Information Item Code (Source) NDC:68828-726 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-726-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/21/2020 Part 9 of 10 ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 SOFT IVORY
homosalate, octisalate, zinc oxide liquidProduct Information Item Code (Source) NDC:68828-717 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength 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) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-717-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/05/2022 Part 10 of 10 ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 NATURAL TAN
homosalate, octisalate, zinc oxide liquidProduct Information Item Code (Source) NDC:68828-718 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7 g in 100 mL Inactive Ingredients Ingredient 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-718-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/05/2022 Labeler - Jafra Cosmetics International (041676479) Establishment Name Address ID/FEI Business Operations Distribuidora Comercial Jafra, S.A. de C.V. 951612777 manufacture(68828-716, 68828-717, 68828-718, 68828-719, 68828-720, 68828-721, 68828-722, 68828-723, 68828-724, 68828-725, 68828-726)
