TRANSLUCENT BROAD SPECTRUM FOUNDATION SPF 50 VERTRA- padimate o, titanium dioxide stick

Translucent Broad Spectrum Foundation SPF 50 by

Drug Labeling and Warnings

Translucent Broad Spectrum Foundation SPF 50 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

Padamite O 7% Sunscreen

Titanium Dioxide 17%

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 products is swallowed, get medical help or contact 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

• immeadiately 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 of 15 or higher and otther 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 Isosterate, 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 50+

Water Resistant (80 minutes)

Color: Translucent

10.5g NET WT. .37 oz.

INGREDIENTS AND APPEARANCE

TRANSLUCENT BROAD SPECTRUM FOUNDATION SPF 50  VERTRA
padimate o, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66990-1015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	7 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	17.45 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5)
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: 66990-1015-2	1 in 1 BOX	10/07/2016
1	NDC: 66990-1015-1	10.5 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(66990-1015)