MINERAL FOUNDATION by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

MINERAL FOUNDATION by

Drug Labeling and Warnings

MINERAL FOUNDATION by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINERAL FOUNDATION SPF 15- titanium dioxide, zinc oxide powder 
J. A. Cosmetics U.S. INC

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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Active Ingredients:

​ ​TITANIUM DIOXIDE (10%)

ZINC OXIDE (15%)

Purpose:

SUNSCREEN

Uses:

HELPS PREVENT SUNBURN

Warning:

For external use only

When Using This Product

• KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Stop use and ask a doctor if

• rash occurs.

KEEP OUT OF REACH OF CHILDREN.

Directions:

• APPLY LIBERALLY AS NEEDED 15 TO 20 MINUTES BEFORE SUN EXPOSURE. REAPPLY AS NEEDED OR AFTER SWIMMING OR TOWEL DRYING.

Inactive Ingredient:

MICA, BISMUTH OXYCHLORIDE, TALC, PARAFFINUM LIQUIDUM (MINERAL OIL), DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA, SODIUM DEHYDROACETATE, TOCOPHERYL ACETATE (VE), BORON NITRIDE

May Contain: TITANUM DIOXIDE (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

MINERAL FOUNDATION  SPF 15
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15   in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
TALC (UNII: 7SEV7J4R1U)
MINERAL OIL (UNII: T5L8T28FGP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BORON NITRIDE (UNII: 2U4T60A6YD)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ULTRAMARINE BLUE (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-103-51	1 in 1 BOX	10/10/2013	12/31/2017
1	NDC: 76354-103-21	2.84 g in 1 CONTAINER; 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	10/10/2013	12/31/2017

Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 3/2014

Document Id: 0a663c4f-ff7c-4b33-94a6-3f3ae3355755

34390-5

Set id: d09a4d91-73c0-4fea-a595-bbfcdda08438

Version: 4

Effective Time: 20140319