BARE SKIN MINERAL COVER SPF27- octinoxate and octisalate powder powder

BARE SKIN by

Drug Labeling and Warnings

BARE SKIN by is a Otc medication manufactured, distributed, or labeled by THEFACESHOP CO., LTD., THEFACESHOP NORTH AMERICA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Octinoxate 3.8 %
Octisalate 2.5 %

Purpose

Sunscreen

Sunscreen

Uses:

Helps prevent sunburn.

Warnings

For external use only.

Do not use on damaged or broken skin

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. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor.
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 only to help prevent sunburn, not skin cancer or early skin aging.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.

Apply an adequate amount on face in a light patting motion by using puff.

OTHER SAFETY INFORMATION

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

May stain or damage some fabrics or surfaces.

Inactive Ingredients:

TALC, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, TITANIUM DIOXIDE, ZINC OXIDE, SILICA, PHENYL TRIMETHICONE, 1,2-HEXANEDIOL, AMINOPROPYL DIMETHICONE, MICA, POLYMETHYLSILSESQUIOXANE, METHICONE, ALUMINA, GLYCERYL CAPRYLATE, RUBUS CHAMAEMORUS SEED EXTRACT,VOLCANIC ASH, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER WATER, WATER, BUTYLENE GLYCOL, CHENOPODIUM QUINOA SEED EXTRACT, FRAGRANCE, IRON OXIDES (CI 77492, CI 77491, CI77499)

QUESTIONS

Questions or comments? Call 1-866-638-8417

Distributed by:

THEFACESHOP NORTH AMERICA, INC.

Santa Fe Springs, CA 90670

PRINCIPAL DISPLAY PANEL

BARE SKIN
MINERAL COVER SUNSCREEN POWDER
N203 NATURAL BEIGE SPF27 PA++
Mineral cover powder keeps skin looking flawless for many hours.
Provides a flawless, smooth finish that keeps makeup looking fresh for many hours.
Creates a blurring effect that smoothes out the curves and pores of the skin.
Contains Perfect Seed to keep skin fresh and clean by taking care of dead skin cells and sebum.

INGREDIENTS AND APPEARANCE

BARE SKIN  MINERAL COVER SPF27
octinoxate and octisalate powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-475
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.57 g  in 15 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.38 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-475-37	1 in 1 CARTON	10/01/2015
1		15 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 not final	part352	10/01/2015

Labeler - THEFACESHOP CO., LTD. (688329416)

Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)

Establishment
Name	Address	ID/FEI	Business Operations
THEFACESHOP CO., LTD.		688329416	label(51523-475)