FOUNDATION BROAD SPECTRUM SPF 35 COOLY BEIGE VERTRA- titanium dioxide stick

Foundation Broad Spectrum SPF 35 Cooly Beige by

Drug Labeling and Warnings

Foundation Broad Spectrum SPF 35 Cooly Beige by is a Otc medication manufactured, distributed, or labeled by Toshiki Pigment Co., ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Titanium Dioxide 23% Sunscreen

PURPOSE

Uses

• helps prevent sunburn

• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

• Higher SPF gives more sunburn protection

• Retains SPF after 80 minutes activity in the water, sweating, or perspiring.

• Provides high protection against sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash or irritation develops and lasts

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions

apply liberally and evenly 15 minutes before sun exposure
apply to all skin exposed to sun
use a water resistant sunscreen if swimming or sweating
reapply: after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months of age: ask a doctor

INACTIVE INGREDIENT

Hexyldecyl Isostearate, Mica, Synthetic Wax, Paraffin, Ozokerite, Polyglyceryl-2 Oleate, Aluminum Hydroxide, Stearic Acid, Ethylene/Propylene Copolymer, Tocopheryl, Fragrance, Iron oxides

PRINCIPAL DISPLAY PANEL

Vertra Elemental Resistance

Foundation

Sunscreen Face Stick

Broad Spectrum SPF 35

Water Resistant (80 minutes)

Color: Cooly Beige

11g NET WT. .39 OZ.

INGREDIENTS AND APPEARANCE

FOUNDATION BROAD SPECTRUM SPF 35 COOLY BEIGE  VERTRA
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66990-1017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
PARAFFIN (UNII: I9O0E3H2ZE)
STEARIC ACID (UNII: 4ELV7Z65AP)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66990-1017-2	1 in 1 CARTON	10/07/2016
1	NDC: 66990-1017-1	11 g in 1 CYLINDER; 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	10/07/2016

Labeler - Toshiki Pigment Co., ltd. (716140285)

Establishment
Name	Address	ID/FEI	Business Operations
Toshiki Pigment Co., ltd.		716140285	manufacture(66990-1017)