Country: United States
Language: English
Source: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Nanophase Technologies Corporation
TOPICAL
OTC DRUG
OTC monograph final
WL-AAE-ZT-O-400- TITANIUM DIOXIDE, ZINC OXIDE LOTION NANOPHASE TECHNOLOGIES CORPORATION _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._ ---------- WL-AAE-ZTO-400 (BULK FOR PROTECT TINTED DAILY CREAM SPF 40) WL-AAE-ZT-O-400 WL-AAE-ZT-O-400 Nanophase Technologies Corporation titanium dioxide, zinc oxide lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:63931-4300 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1 g in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1 g in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB) 1 g in 1 g PRODUCT CHARACTERISTICS COLOR brown SCORE SHAPE SIZE FLAVOR IMPRINT CODE CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:63931- 4300-1 150000 g in 1 DRUM; Type 0: Not a Combination Product 10/16/2018 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph final part352 10/16/2018 LABELER - Nanophase Technologies Corporation (623502044) Revised: 1/2022 Read the complete document