MINERAL CONCEALER description, usages, side effects, indications, overdosage, supplying and lots more!

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MINERAL CONCEALER

J. A. Cosmetics U.S. INC
J. A. Cosmetics U.S. INC




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients:

​TITANIUM DIOXIDE (10%)

ZINC OXIDE (15%)

Purpose

Purpose:

SUNSCREEN

Uses

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

MINERAL CONCEALER

TITANIUM DIOXIDE, ZINC OXIDE POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76354-109
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 10 g
Zinc Oxide Zinc oxide 15 1

Inactive Ingredients

Ingredient Name Strength
MICA
BISMUTH OXYCHLORIDE
talc
Mineral Oil
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
SILICON DIOXIDE
.ALPHA.-TOCOPHEROL ACETATE
BORON NITRIDE
SODIUM DEHYDROACETATE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MANGANESE VIOLET
Ultramarine Blue

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76354-109-21 2.84 in 1 CONTAINER
2 NDC:76354-109-51 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-10-10


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