JJF FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38- titanium dioxide stick

JJF Foundation Sunscreen Face Broad Spectrum SPF 38 by

Drug Labeling and Warnings

JJF Foundation Sunscreen Face Broad Spectrum SPF 38 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 swallowed, get medical help or call a Poison Control Center right away.

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 or irritation develops and lasts.

DOSAGE & ADMINISTRATION

Directions

• apply liberally and evenly 15 minutes before sun exposure

• children under 6 months of age: ask a doctor

• 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

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

Foundation Sunscreen Face Stick

Broad Spectrum SPF 38

Water Resistant (80 minutes)

Color: Ehukai Beige

11g NET Wt. 0.39 oz

INGREDIENTS AND APPEARANCE

JJF FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38 
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66990-1018
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
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MICA (UNII: V8A1AW0880)
PARAFFIN (UNII: I9O0E3H2ZE)
CERESIN (UNII: Q1LS2UJO3A)
HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66990-1018-1	11 g in 1 BOX; Type 0: Not a Combination Product	02/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/14/2018

Labeler - Toshiki Pigment Co., Ltd (716140285)

Establishment
Name	Address	ID/FEI	Business Operations
Toshiki Pigment Co., Ltd		716140285	manufacture(66990-1018)