Label: SUNNY SKIN SUPER SUN SPF50- zinc oxide cream

  • 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 October 28, 2022

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  • Active ingredient

    Zinc Oxide 22.75%

  • Purpose

    Mineral Sunscreen

  • Uses

    Help Prevent Sunburn. If uses as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early ageing 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 doctor is rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control centre right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    For sunscreen use: • apply liberally 15 mins before sun exposure • apply to all skin exposed to the sun • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours.
    Children under 6 months old of age: ask doctor. 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 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses.

  • Inactive Ingredients

    MediumChain(Caprylic/capric) triglycerides, Castor (Ricinus communis) Seed Oil, Coco-octanoate (Coco-caprylate/caprate), Coconut (Cocos nucifera) Oil, Candellila wax, Hydrogenated castor oil, polyglyceryl-3 polyricinoleate, Tocopheryl acetate, Iron oxides, isostearic acid, IBR-TCLC in Jojoba Oil 0705 (Simmondsia Chinensis (Jojoba) Seed Oil (and) Squalane (and) Solanum Lycopersicum (Tomato) Fruit Extract).

  • Other information

    protect this product from excessive heat and direct sun.

    Questions or Comments?
    Email hello@sunnyskin.com

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    SUNNY SKIN SUPER SUN SPF50 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83070-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SOLANUM LYCOCARPUM FRUIT (UNII: GL29VWX729)  
    SQUALANE (UNII: GW89575KF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83070-001-011 in 1 BOX10/27/2022
    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 not finalpart34810/27/2022
    Labeler - MCDONALD MULTINATIONAL PTY LTD (746817764)
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