Label: SKINSUIT FACE SPF 50- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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  • ACTIVE INGREDIENT

    ZINC OXIDE 12%

  • PURPOSE

    SUNSCREEN

  • USES

    • HELPS PREVENT SUNBURN
    • IF USED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY SUN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    DO NOT USE ON

    • BROKEN SKIN
    • SERIOUS BURNS

    WHEN USING THIS PRODUCT

    • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

    STOP USE AND ASK A DOCTOR IF

    • RASH OR IRRITATION DEVELOPS AND LASTS
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    • IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
  • SUN PROTECTION MEASURES:

    SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE RISK, REGULARLY USE A SUNSCREEN WITH BROAD SPECTRUM SPF VALUE OF 15+ AND OTHER SUN PROTECTION MEASURES

    • LIMIT TIME IN THE SUN FROM 10AM - 2PM
    • WEAR LONG SLEEVED SHIRT, PANTS, HATS, AND SUNGLASSES

  • DIRECTIONS

    APPLY EVENLY TO FACE 15 MINUTES BEFORE EXPOSURE.

    • REAPPLY EVERY 2 HOURS
    • REAPPLY AS NEEDED AFTER SWIMMING OR PERSPIRING
    • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

  • INACTIVE INGREDIENT

    WATER, C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, ISODODECANSE, LAURYL PEG-8 DIMETHICONE, POLYMETHYLSILSESQUIOXANE, OCTYLDODECYL NEOPENTANOATE, PROPANEDIOL, DIMETHICONE, CAPRYLYL METHICONE, NIACINAMIDE, DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER, TRILAURETH-4 PHOSPHATE, ALLANTOIN, BISABOLOL, CAPRYL GLYCOL, ETHYHEXYLGLYCERIN, HEXYLENE GLYCOL, IRON OXIDES, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, PEG-10, PHENOXYETHANOL, SODIUM CHLORIDE, SODIUM HYDROXIDE, TETRASODIUM GLUTAMATE DIACETATE, TOCOPHEROL.

  • OTHER INFORMATION

    PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN. STORE AT 40° - 95°F (5° - 35°C).

  • QUESTIONS?

    1-866-325-7546

    MONDAY - FRIDAY (9 A.M. TO 5 P.M. PST)

  • PRINCIPAL DISPLAY PANEL

    0-LBL_SkinSuit Face SPF-50

  • INGREDIENTS AND APPEARANCE
    SKINSUIT FACE  SPF 50
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46007-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46007-204-1150 mL in 1 TUBE; Type 0: Not a Combination Product01/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/19/2012
    Labeler - Skin Authority LLC (136549396)
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