FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38 KONA GOLD VERTRA- titanium dioxide stick

Foundation Sunscreen Face Broad Spectrum SPF 38 Kona Gold by

Drug Labeling and Warnings

Foundation Sunscreen Face Broad Spectrum SPF 38 Kona Gold 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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

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 value 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m.-2p.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 Oxide(CI 77491), Iron Oxide(CI 77492), Iron Oxide(CI 77499)

PRINCIPAL DISPLAY PANEL

Vertra Elemental Resistance

Foundation

Sunscreen Face Stick

Broad Spectrum SPF 38

Water Resistant (80 minutes)

Color Kona Gold

11g Net Wt. .39 oz

INGREDIENTS AND APPEARANCE

FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38 KONA GOLD  VERTRA
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66990-1016
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66990-1016-2	1 in 1 BOX	04/02/2018
1	NDC: 66990-1016-1	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	04/02/2018

Labeler - Toshiki Pigment Co., Ltd (716140285)

Establishment
Name	Address	ID/FEI	Business Operations
Toshiki Pigment Co., Ltd		716140285	manufacture(66990-1016)