Label: BADGER CLEAR ZINC SUNSCREEN CREAM BROAD SPECTRUM SPF 40- zinc oxide cream
- NDC Code(s): 62206-4719-0
- Packager: W.S. Badger Company, Inc.
- 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 September 30, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
-
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
- DO NOT USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- For full protection, apply liberally (2mg/cm 2 of skin) to all exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect.
Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- 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 10am-2pm
- Wear long-sleeved shirts, pants, hats, and sunglasses
- For children under 6 months of age: ask a doctor.
-
Ingredients
*Helianthus Annuus ( Sunflower) Seed Oil, *Cera Alba ( Beeswax), *Simmondsia Chinensis ( Jojoba) Seed Oil, Tocopherol ( SunflowerVitamin E), *Calendula Officinalis ( Calendula) Flower Extract, *Anthemis Nobilis ( Roman Chammomile) Flower Oil, *Hippophae Rhamnoides ( Seabuckthorn) Fruit Extract.
*= Organic
- Other Information
- PRINCIPAL DISPLAY PANEL - 87 mL Tube Label
-
INGREDIENTS AND APPEARANCE
BADGER CLEAR ZINC SUNSCREEN CREAM BROAD SPECTRUM SPF 40
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62206-4719 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 22.5 g in 100 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62206-4719-0 68 g in 1 CAN; Type 0: Not a Combination Product 02/11/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/11/2021 Labeler - W.S. Badger Company, Inc. (963242326) Establishment Name Address ID/FEI Business Operations W.S. BADGER COMPANY, INC. 963242326 manufacture(62206-4719)
