Label: ALBA SUNBLOCK FACIAL SPF 20- zinc oxide, titanium dioxide cream
- 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 June 25, 2010
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ALBA SUNBLOCK FACIAL SPF 20
zinc oxide, titanium dioxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2387 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Oxide 8.0 g in 100 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 1.0 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2387-4 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/28/2009 Labeler - The Hain Celestial Group, Inc. (858894996) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 858894996 manufacture