ORGANIC WEAR 100% NATURAL ORIGIN TINTED MOISTURIZER SPF 15- titanium dioxide cream
Baja Fur, S.A. de C.V.

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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OW Tinted Moisturizer 2154-2157, 71413-145

Carton PDP

ORGANIC WEAR 100% NATURAL ORIGIN TINTED MOISTURIZER SPF 15
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71413-145
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.95 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
SUNFLOWER OIL (UNII: 3W1JG795YI)
AVOCADO OIL (UNII: 6VNO72PFC1)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
TALC (UNII: 7SEV7J4R1U)
SHEA BUTTER (UNII: K49155WL9Y)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
ALGINIC ACID (UNII: 8C3Z4148WZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71413-145-02	1 in 1 BOX	02/01/2009
1	NDC:71413-145-01	44 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/01/2009

Labeler - Baja Fur, S.A. de C.V. (821533098)

Revised: 9/2021

Document Id: cd2b9df0-5b4d-d25c-e053-2a95a90a2227

Set id: cd2b9d65-c9aa-8492-e053-2a95a90a399e

Version: 1

Effective Time: 20210929

Baja Fur, S.A. de C.V.