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

Product label

image description

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-432-01	1 in 1 KIT; Type 0: Not a Combination Product	08/21/2020	09/15/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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 SOFT IVORY
homosalate, octisalate, zinc oxide cream

Product Information
Item Code (Source)	NDC:68828-433
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-433-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/21/2020	09/15/2022

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 Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-434-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/21/2020	09/15/2022

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 Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-435-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/21/2020	09/15/2022

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 Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-436-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/21/2020	09/15/2022

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 Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-437-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/21/2020	09/15/2022

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 Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-438-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/21/2020	09/15/2022

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 Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-439-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/21/2020	09/15/2022

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 Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-440-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/21/2020	09/15/2022

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 Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-441-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/21/2020	09/15/2022

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 Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-442-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/21/2020	09/15/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/21/2020	09/15/2022

Labeler - Jafra cosmetics International (041676479)

Name	Address	ID/FEI	Business Operations
Establishment
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-432, 68828-433, 68828-434, 68828-435, 68828-436, 68828-437, 68828-438, 68828-439, 68828-440, 68828-441)

Revised: 9/2022

Document Id: e8cce259-13fb-7a8e-e053-2995a90aa3b2

Set id: c0ab86d0-b68a-5c66-e053-2995a90adf7e

Version: 4

Effective Time: 20220916

Jafra cosmetics International