Label: ZEBS ORGANICS SUNSCREEN- zinc oxide lotion
- NDC Code(s): 70397-2017-1
- Packager: New Era Naturals 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.
Updated October 24, 2016
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- INGREDIENTS AND APPEARANCE
ZEBS ORGANICS SUNSCREEN
zinc oxide lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70397-2017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 11 g in 90 g Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) 22 g in 90 g WHITE WAX (UNII: 7G1J5DA97F) 10 g in 90 g SHEA BUTTER (UNII: K49155WL9Y) 10 g in 90 g SUNFLOWER OIL (UNII: 3W1JG795YI) 32 g in 90 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70397-2017-1 88.4 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2018 Labeler - New Era Naturals LLC (080099019)