SHISEIDO SUN PROTECTION FOUNDATION TRANSLUCENT- octinoxate and titanium dioxide stick

SHISEIDO SUN PROTECTION FOUNDATION by

Drug Labeling and Warnings

SHISEIDO SUN PROTECTION FOUNDATION by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
TITANIUM DIOXIDE 9.2%	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

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• 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 of 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: Ask a doctor

Inactive Ingredients

HYDROGENATED POLYDECENE, POLYMETHYL METHACRYLATE, DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, BARIUM SULFATE, KAOLIN, POLYETHYLENE, SORBITAN SESQUIISOSTEARATE, MICROCRYSTALLINE WAX, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, ZINC MYRISTATE, TOCOPHERYL ACETATE, THIOTAURINE, STEARYL GLYCYRRHETINATE, COPERNICIA CERIFERA (CARNAUBA) WAX, METHICONE, SILICA, ALUMINA, GLYCERIN, TRIETHOXYCAPRYLYLSILANE, TOCOPHEROL, BHT, SODIUM CARBONATE, FRAGRANCE, MICA, TITANIUM DIOXIDE,

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022

SHISEIDO DIST. NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton

SHISEIDO

37

Sun Protection
Stick Foundation
(Translucent)

BROAD SPECTRUM
SPF 37

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

9g NET WT. .31 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SUN PROTECTION FOUNDATION   TRANSLUCENT
octinoxate and titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-338
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	441 mg  in 9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	828 mg  in 9 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
KAOLIN (UNII: 24H4NWX5CO)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
ZINC MYRISTATE (UNII: K09A9E2GGO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
THIOTAURINE (UNII: NQZ2D7AO62)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
CARNAUBA WAX (UNII: R12CBM0EIZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CARBONATE (UNII: 45P3261C7T)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-338-20	1 in 1 CARTON
1		9 g in 1 CARTRIDGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2013

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-338) , ANALYSIS(52686-338)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-338)