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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 17, 2021

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  • Drug Facts

  • Active ingredients

    Zinc oxide 22%

    Purpose

    Sunscreen

  • 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 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
    • 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
  • 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 not finalpart35205/01/2019
    Labeler - SIBORG LLC (102875148)