Label: BADGER KIDS SPF 30 SUNSCREEN- zinc oxide lotion 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 09/13

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

  • Active Ingredient

    Non-Nano Uncoated Zinc Oxide 12%

    Close
  • Purpose

    Sunscreen

    Close
  • 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.

    Close
  • Warnings:

    For external use only

    Close
  • Do not use

    Do not use on damaged or broken skin. Stop and ask a doctor if rash occurs.

    Close
  • When using this product

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

    Close
  • Keep out of reach of children

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

    Close
  • Directions:

    Directions: • For full protection, apply liberally (2 mg/cm2 of skin) 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating Reapply: • At least every 2 hours 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 am - 2 pm • Wear long sleeved shirts, pants, hats, and sunglasses • For children under 6 months: ask a doctor.

    Close
  • Ingredients

    *Aloe Barbadensis (Aloe) Leaf Juice, *Helianthus Annuus (Sunflower) Oil, Carthamus Tinctorius (Safflower) Oleosomes, *Sucrose Cocoate (from Coconut), Water, *Citrus Aurantium Dulcis (Sweet Orange) Essential Oil, Microcrystalline Cellulose, Citric Acid (from Non-GMO Corn), Leuconostoc Ferment Filtrate (from Radish), *Glycerin (from Sustainable Palm), *Citrus Tangerina (Tangerine) Essential Oil, *Aloe Barbadensis (Aloe) Extract, Tocopherol (Sunflower Vitamin E), Gluconolactone (from Non-GMO Corn), *Vanilla Planifolia (Vanilla) CO2 Extract, Xanthan Gum, *Lecithin (from Soybean), Cellulose Gum. *=Certified Organic

    Close
  • Other Information:

    Store at temperatures below 90°F.

    Close
  • Principal Display Panel

    Image Components

    image description

    Close
  • INGREDIENTS AND APPEARANCE
    BADGER KIDS SPF 30 SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51514-0302
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 12 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SUNFLOWER OIL  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES  
    SUCROSE COCOATE  
    ORANGE OIL  
    CELLULOSE, MICROCRYSTALLINE  
    CITRIC ACID MONOHYDRATE  
    MANDARIN OIL  
    ALOE VERA LEAF  
    GLYCERIN  
    TOCOPHEROL  
    GLUCONOLACTONE  
    VANILLA  
    XANTHAN GUM  
    LECITHIN, SOYBEAN  
    CARBOXYMETHYLCELLULOSE SODIUM  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51514-0302-1 118 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 03/01/2013
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    Name Address ID/FEI Business Operations
    Autumn Harp, Inc. 064187883 manufacture(51514-0302)
    Close