CIELE FILTER AND PROTECT- titanium dioxide, zinc oxide powder

Ciele Filter and Protect by

Drug Labeling and Warnings

Ciele Filter and Protect by is a Otc medication manufactured, distributed, or labeled by Ciele. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAI-ZT-P-1910

INGREDIENTS AND APPEARANCE

CIELE FILTER AND PROTECT 
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83103-1910
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.125 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.225 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPANEDIOL (UNII: 5965N8W85T)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
NIACINAMIDE (UNII: 25X51I8RD4)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
ISODECYL SALICYLATE (UNII: S7097PFP4C)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHICONE (20 CST) (UNII: 6777U11MKT)
ISOCETETH-10 (UNII: 1K92T9919H)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENYLPROPANOL (UNII: 0F897O3O4M)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83103-1910-2	1 in 1 CARTON	07/25/2023
1	NDC: 83103-1910-1	10 g in 1 JAR; 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	07/25/2023

Labeler - Ciele (105041170)