Label: PURE ZINC OXIDE SUNSCREEN 30- zinc oxide salve
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Contains inactivated NDC Code(s)
NDC Code(s): 72165-158-22 - Packager: Klar Medical
- 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 March 22, 2018
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INGREDIENTS AND APPEARANCE
PURE ZINC OXIDE SUNSCREEN 30
zinc oxide salveProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72165-158 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 g Inactive Ingredients Ingredient Name Strength OLIVE OIL (UNII: 6UYK2W1W1E) JOJOBA OIL (UNII: 724GKU717M) SHEA BUTTER (UNII: K49155WL9Y) YELLOW WAX (UNII: 2ZA36H0S2V) COCONUT OIL (UNII: Q9L0O73W7L) SUNFLOWER OIL (UNII: 3W1JG795YI) TOCOPHEROL (UNII: R0ZB2556P8) CASTOR OIL (UNII: D5340Y2I9G) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72165-158-22 85 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2018 Labeler - Klar Medical (080891001)
