Label: ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 COCOA- homosalate, octisalate, zinc oxide cream

  • NDC Code(s): 68828-431-01
  • 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 August 20, 2020

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

  • ACTIVE INGREDIENT

    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

    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 INGREDIENT

    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

    30 ML e 1 FL OZ (US)

    Always foundation - Cocoa

  • INGREDIENTS AND APPEARANCE
    ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 COCOA 
    homosalate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-431
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    KAOLIN (UNII: 24H4NWX5CO)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-431-0130 mL in 1 TUBE; Type 0: Not a Combination Product08/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/20/2020
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-431)