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

  • NDC Code(s): 68828-432-01, 68828-433-01, 68828-434-01, 68828-435-01, view more
    68828-436-01, 68828-437-01, 68828-438-01, 68828-439-01, 68828-440-01, 68828-441-01, 68828-442-01
  • 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 April 23, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients

    Homosalate 4.25% Purpose Sunscreen

    Octisalate 4.75% Purpose Sunscreen

    Zinc Oxide 7.0% Purpose Sunscreen

  • PURPOSE

    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

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    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 SAFETY INFORMATION

    Protect this product from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    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

  • INGREDIENTS AND APPEARANCE
    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)