Label: ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX- zinc oxide oil

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

Drug Label Information

Updated December 12, 2023

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  • Drug Facts

  • Active ingredients

    Zinc oxide 22%

    Purpose

    Sunscreen

    Inactive Ingredients

    Inactive ingredients
    dicaprylyl carbonate, isononyl isononanoate,
    coco-caprylate, C12-15 alkyl benzoate, ethylhexyl
    palmitate, hydrogenated dimer
    dilinoleyl/dimethylcarbonate copolymer, magnesium
    stearate, argania spinosa kernel oil, tocopherol,
    caesalpinia spinosa fruit pod extract, helianthus
    annuus (sunflower) sprout extract, sodium
    hyaluronate, tocopheryl acetate, maltodextrin,
    phenethyl alcohol, polyhydroxystearic acid,
    trinydroxystearin, mica, aqua (water),
    ethylhexylglycerin, sodium benzoate,
    iron oxides (CI 77499), titanium dioxide (Cl 77891)

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun See Directions
  • 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 doctor if

    rash occurs

    Keep out of reach of children.

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

  • Directions

    • apply liberally and evenly 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • 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: Sun Protection Measures:
    • 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
  • Other information

    dicaprylyl carbonate, isononyl isononanoate, coco-caprylate, C12-15 alkyl benzoate, ethylhexyl palmitate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, magnesium stearate, argania spinosa kernel oil, tocopherol, caesalpinia spinosa fruit pod extract, helianthus annuus (sunflower) sprout extract, sodium hyaluronate, tocopheryl acetate, maltodextrin, phenethyl alcohol, polyhydroxystearic acid, trihydroxystearin, mica, aqua (water), ethylhexylglycerin, sodium benzoate, iron oxides (CI 77499), titanium dioxide (CI 77891)

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX 
    zinc oxide oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70803-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION220 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
    HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    MICA (UNII: V8A1AW0880)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70803-250-011 in 1 BOX05/01/2019
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2019
    Labeler - SIBORG LLC (102875148)