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

MINERAL CONCEALER by

Drug Labeling and Warnings

MINERAL CONCEALER 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 CONCEALER SPF 20- 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

Skin Cancer/Skin Aging Alert

• Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to help preven sunburn, not skin cancer or skin aging.

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.

Sun Protection Measures:

Spending time in the sun increases your risk of cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 am-2 pmWear long-sleeved shirt, pants, hats and sunglasses

Children under 6 months of age: Ask doctor

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredient:

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

May Contain: IRON OXIDES (CI 77491, CI 77492, CI 77499), MANGANESE VIOLET (CI 77742), ULTRAMARINES (CI 77007)

MINERAL CONCEALER  SPF 20
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-109
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)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
ULTRAMARINE BLUE (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-109-51	1 in 1 BOX	10/10/2013	12/31/2017
1	NDC: 76354-109-21	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: 65da73ee-7a83-446f-bc1b-8c43b85d280e

34390-5

Set id: da2e912f-e111-4b46-b81a-a28b10afe5e0

Version: 4

Effective Time: 20140319

 

J. A. Cosmetics U.S. INC