Ciele Filter and Protect

CIELE FILTER AND PROTECT- titanium dioxide, zinc oxide powder
Ciele

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.

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/25/2023

Labeler - Ciele (105041170)

Ciele Filter and Protect

WL-AAI-ZT-P-1910