OW Tinted Moisturizer 2154-2157, 71413-145

Organic Wear 100% Natural Origin Tinted Moisturizer by

Drug Labeling and Warnings

Organic Wear 100% Natural Origin Tinted Moisturizer by is a Otc medication manufactured, distributed, or labeled by Baja Fur, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71413-145-02	1 in 1 BOX	02/01/2009	08/09/2022
1	NDC: 71413-145-01	44 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2009	08/09/2022

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

Revised: 8/2022

Document Id: e5d36034-acb9-6703-e053-2a95a90ad0bb

34390-5

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

Version: 2

Effective Time: 20220809