Label: SUPERNATURAL AIRBRUSHED CANVAS BROAD SPECTRUM SPF 15 SUNSCREEN RICH- zinc oxide cream

  • NDC Code(s): 50184-1029-1, 50184-1029-2
  • Packager: philosophy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • Active Ingredients

    Zinc Oxide (5.%)

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  • Purpose

    Sunscreen

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  • Keep out of reach of children.

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

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  • 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
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  • 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.

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  • Directions

    • apply liberally 15 minutes before sun exposure on clean, dry skin
    • 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 of 15 or higher and other sun protection measures, including:

    • limit time in the sun, especially from 10 a.m.-2p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
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  • Inactive Ingredients

    caprylyl glycol, silica, aluminum hydroxide, phenoxyethanol, triethoxycaprylylsilane, sodium dehydroacetate, bismuth oxychloride (ci 77163), mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499).

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  • Other Information

    • protect this product from excessive heat and direct sun
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  • Questions or Comments?

    Call toll-free 1-800-568-3151 from 6 a.m.-5p.m. MST (Monday-Friday)

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  • INGREDIENTS AND APPEARANCE
    SUPERNATURAL AIRBRUSHED CANVAS BROAD SPECTRUM SPF 15 SUNSCREEN  RICH
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50184-1029
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 882.7 mg  in 9.1 g
    Inactive Ingredients
    Ingredient Name Strength
    CAPRYLYL GLYCOL  
    SILICON DIOXIDE  
    ALUMINUM HYDROXIDE  
    PHENOXYETHANOL  
    TRIETHOXYCAPRYLYLSILANE  
    SODIUM DEHYDROACETATE  
    BISMUTH OXYCHLORIDE  
    MICA  
    TITANIUM DIOXIDE  
    FERRIC OXIDE RED  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50184-1029-2 1 in 1 BOX
    1 NDC:50184-1029-1 9.1 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 03/01/2013
    Labeler - philosophy (948102256)
    Establishment
    Name Address ID/FEI Business Operations
    Mana Products Inc. 078870292 manufacture(50184-1029)
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