Label: MADE OF BROAD SPECTRUM SPF 30 NON-NANO ZINC OXIDE SUNSCREEN- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71439-050-16 - Packager: MADEOF, LLC
- 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 January 17, 2020
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- 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
- Diretions for full protection, apply liberally (2mg/cm2) to all exposed skin 15 minutes before sun exposure then rub it in to reduce whitening effect.
Reapply:
- After 40 minutes of swimming or sweating • Immediately after towel drying. • At least every two 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 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 six months of age ask a doctor.
- Ingredients
- Other information:
- PRINCIPAL DISPLAY PANEL - 118 ml Tube
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INGREDIENTS AND APPEARANCE
MADE OF BROAD SPECTRUM SPF 30 NON-NANO ZINC OXIDE SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71439-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 mL Inactive Ingredients Ingredient Name Strength VANILLA PLANIFOLIA OIL (UNII: 0A3F415158) ARGAN OIL (UNII: 4V59G5UW9X) RASPBERRY SEED OIL (UNII: 9S8867952A) TOCOPHEROL (UNII: R0ZB2556P8) COCOA BUTTER (UNII: 512OYT1CRR) COCONUT OIL (UNII: Q9L0O73W7L) SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71439-050-16 1 in 1 CARTON 09/05/2017 1 118 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/05/2017 Labeler - MADEOF, LLC (080635957)