Label: BADGER ACTIVE SPF 30 MINERAL SUNSCREEN- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62206-3031-1 - Packager: W.S. Badger Company, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 June 1, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
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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.
- Warnings
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Directions
- For full protection, apply liberally (2mg/cm 2 of skin) to all exposed skin 15 minutes before sun exposure.
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
- Other Information
- PRINCIPAL DISPLAY PANEL - 87 ml Tube Label
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INGREDIENTS AND APPEARANCE
BADGER ACTIVE SPF 30 MINERAL SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62206-3031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 18.75 g in 100 mL Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) TOCOPHEROL (UNII: R0ZB2556P8) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62206-3031-1 87 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 06/01/2022 Labeler - W.S. Badger Company, Inc. (963242326) Establishment Name Address ID/FEI Business Operations W.S. Badger Company, Inc. 963242326 manufacture(62206-3031)
