SKIN BRIGHTENING SPF 50 PA- octinoxate, titanium dioxide and zinc oxide powder powder

SKIN BRIGHTENING by

Drug Labeling and Warnings

SKIN BRIGHTENING 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 6.0 %

Titanium Dioxide 11.6 %

Zinc Oxide 2.9 %

Purpose

Sunscreen

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.

Dispense an adequate amount onto the puff and apply to skin. Pat skin lightly to boost absorption.

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, Methyl Methacrylate Crosspolymer, Silica, Nylon-12, Trimethylolpropane Triethylhexanoate, Phenyl Trimethicone, Ethylene/Acrylic Acid Copolymer, HDI/Trimethylol Hexyllactone Crosspolymer, Methicone, Magnesium Myristate, Ethylhexylglycerin, Caprylyl Glycol, Dimethicone, Triethoxycaprylylsilane, Volcanic Ash, Glycyrrhiza Glabra (Licorice) Root Extract, Chenopodium Quinoa Seed Extract, Chamomilla Recutita (Matricaria) Flower Water, Butylene Glycol, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Water, Rubus Chamaemorus Seed Extract, Saccharomyces Ferment, Phenoxyethanol, Fragrance, Mica (CI 77019), Iron Oxides (CI 77491, CI 77492, CI 77499)

QUESTIONS

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

Distributed by:

THEFACESHOP NORTH AMERICA, INC.

Santa Fe Springs, CA 90670

PRINCIPAL DISPLAY PANEL

SKIN BRIGHTENING

UV SUNSCREEN COMPACT POWDER

V203 NATURAL BEIGE SPF 50+ PA+++

Our UV compact keeps skin tone looking clear and bright for long hours.

Features a whitening effect that brightens skin tone.

Contains Perfect Seed to keep skin clean and fresh by taking care of dead skin cells and sebum.

INGREDIENTS AND APPEARANCE

SKIN BRIGHTENING  SPF 50 PA
octinoxate, titanium dioxide and zinc oxide powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-373
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.66 g  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.28 g  in 11 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.32 g  in 11 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-373-25	1 in 1 CARTON	10/01/2015
1		11 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(51523-373)