ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 DELUXE SAMPLE KIT- homosalate, octisalate, zinc oxide 
Jafra cosmetics International

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.

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Always Foundation Makeup Broad Spectrum SPF 15 Deluxe Sample Kit

Active Ingredients

Homosalate 4.25% Purpose Sunscreen

Octisalate 4.75% Purpose Sunscreen

Zinc Oxide 7.0% Purpose Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Keep 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 occurs

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

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

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

Protect this product from excessive heat and direct sun

JAFRA beauty

always

Foundation Makeup Broad Spectrum SPF 15 Deluxe Sample Kit

10 testers at 7.5 ml .25 FL OZ (US) each

Total Contents 75 ml 2.53 FL OZ (US)

always deluxe kit spf 15

ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 DELUXE SAMPLE KIT 
homosalate, octisalate, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-432
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-432-011 in 1 KIT; Type 0: Not a Combination Product08/21/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 7.5 mL  in 75 
Part 21 TUBE 7.5 mL  in 75 
Part 31 TUBE 7.5 mL  in 75 
Part 41 TUBE 7.5 mL  in 75 
Part 51 TUBE 7.5 mL  in 75 
Part 61 TUBE 7.5 mL  in 75 
Part 71 TUBE 7.5 mL  in 75 
Part 81 TUBE 7.5 mL  in 75 
Part 91 TUBE 7.5 mL  in 75 
Part 101 TUBE 7.5 mL  in 75 
Part 1 of 10
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 SOFT IVORY 
homosalate, octisalate, zinc oxide cream
Product Information
Item Code (Source)NDC:68828-433
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.25 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-433-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/21/2020
Part 2 of 10
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 NATURAL TAN 
homosalate, octisalate, zinc oxide cream
Product Information
Item Code (Source)NDC:68828-434
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.25 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-434-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/21/2020
Part 3 of 10
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 GOLDEN TAN 
homosalate, octisalate, zinc oxide cream
Product Information
Item Code (Source)NDC:68828-435
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.25 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-435-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/21/2020
Part 4 of 10
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 COCOA 
homosalate, octisalate, zinc oxide cream
Product Information
Item Code (Source)NDC:68828-436
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.25 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-436-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/21/2020
Part 5 of 10
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 SHELL 
homosalate, octisalate, zinc oxide cream
Product Information
Item Code (Source)NDC:68828-437
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.25 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-437-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/21/2020
Part 6 of 10
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 BUFF 
homosalate, octisalate, zinc oxide cream
Product Information
Item Code (Source)NDC:68828-438
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.25 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-438-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/21/2020
Part 7 of 10
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 NATURAL 
homosalate, octisalate, zinc oxide cream
Product Information
Item Code (Source)NDC:68828-439
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.25 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-439-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/21/2020
Part 8 of 10
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 IVORY 
homosalate, octisalate, zinc oxide cream
Product Information
Item Code (Source)NDC:68828-440
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.25 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-440-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/21/2020
Part 9 of 10
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 BISQUE 
homosalate, octisalate, zinc oxide cream
Product Information
Item Code (Source)NDC:68828-441
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.25 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-441-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/21/2020
Part 10 of 10
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 HONEY 
homosalate, octisalate, zinc oxide cream
Product Information
Item Code (Source)NDC:68828-442
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.25 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-442-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/21/2020
Labeler - Jafra cosmetics International (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-432, 68828-433, 68828-434, 68828-435, 68828-436, 68828-437, 68828-438, 68828-439, 68828-440, 68828-441)

Revised: 4/2021
Document Id: c0ab86dd-26fc-7445-e053-2995a90a2565
Set id: c0ab86d0-b68a-5c66-e053-2995a90adf7e
Version: 1
Effective Time: 20210423
 
Jafra cosmetics International