Label: ACTIVATED MINERAL SUNSCREEN TINTED cream

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

Drug Label Information

Updated December 4, 2025

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

  • Active Ingredients

    Zinc Oxide 14.2%

  • 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

  • Warnings

    For external use only

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a docor if rash occurs

    Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously 15 minutes before sun exposure
    • reapply: •at least every 2 hours.

    • use a water resistant sunscreen if swimming or sweating
    • 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
    value 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-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor

  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Niacinamide, Butyloctyl Salicylate, Propanediol, Squalene, Aloe Barbadensis Leaf Juice, Sodium Acrylate/Sodium Acyloyldimethyl Tauarate Copolymer, 1,2-Hexanediol, Cetyl Alcohol, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyacetophenone, Polyisobutene, Glycerin, Glyceryl Stearate, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Vaccinium Vitis-Idaea Fruit Extract, Xanthan Gum, Caprylyl/Capryl Glucoside, Sorbitan Oleate, Phenoxyethanol, Jojoba Esters, Citric Acid, Gluconolactone, Plankotn Extract, Alumina, Sodium Benzoate, Potassium Sorbate, Silica, Calcium Glucate. May Contain (+/-): Titanium Dioxide (CI77891), Iron Oxides (CI 774941, 77492, 77499)

  • Other Information

    • protect the product in this container from excessive
    heat and direct sun

  • Questions or Comments?

    Call our Sunshine Concierge: 855-744-6366 (855-Shine-On)

  • Purpose

    Sunscreen

  • Keep out of reach of children.

    Keep out of reach of children.

  • Topical

    Topical

  • Principal Display Panel

    83083-002

  • INGREDIENTS AND APPEARANCE
    ACTIVATED MINERAL SUNSCREEN TINTED 
    activated mineral sunscreen tinted cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83083-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE142.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SQUALANE (UNII: GW89575KF9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    VACCINIUM VITIS-IDAEA FRUIT OIL (UNII: 16Y54799WZ)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ALUMINUM (UNII: CPD4NFA903)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SILICON (UNII: Z4152N8IUI)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83083-002-501 in 1 CARTON03/25/2025
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/25/2025
    Labeler - Reve Skincare LLC (118831764)