Label: SKINSUIT LIP SPF 30- zinc oxide gel

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

Drug Label Information

Updated October 5, 2023

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  • ACTIVE INGREDIENT

    ZINC OXIDE 10%

  • 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 UPPER AND LOWER LIP 15 MINUTES BEFORE EXPOSURE. NATURAL TINT WILL ABSORB AND BECOME SHEER.

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

  • INACTIVE INGREDIENT

    HYDROGENATED POLY(C6-14 OLEFIN), SQUALANE, BUTYLOCTYL SALICYLATE, CETEARYL DIMETHICONE, ISODODECANE, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, CAPRYLYL METHICONE, SYNTHETIC FLUORPHLOGOPITE, IRON OXIDE, LECITHIN, BUTYLENE/ETHYLENE/STYRENE COPOLYMER, CAPRYLYL GLYCOL, DIMETHICONE, DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, PHENYLPROPANOL, PROPANEDIOL, TIN OXIDE, TITANIUM DIOXIDE (CI 77891), 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 LIP  SPF 30
    zinc oxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46007-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
    SQUALANE (UNII: GW89575KF9)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)  
    ISODODECANE (UNII: A8289P68Y2)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46007-205-113.2 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/02/2020
    Labeler - Skin Authority LLC (136549396)
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