SHISEIDO ULTIMATE SUN PROTECTION PLUS- octinoxate, octocrylene, titanium dioxide, and zinc oxide cream

SHISEIDO ULTIMATE SUN PROTECTION PLUS by

Drug Labeling and Warnings

SHISEIDO ULTIMATE SUN PROTECTION PLUS by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:	Purpose
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
TITANIUM DIOXIDE 1.7%	Sunscreen
ZINC OXIDE 19.3%	Sunscreen

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

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

WATER, SD ALCOHOL 40-B, ISOHEXADECANE, BUTYLENE GLYCOL, DIMETHICONE, ISOPROPYL MYRISTATE, POLYMETHYL METHACRYLATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, XYLITOL, GLYCERIN, DISTEARDIMONIUM HECTORITE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, ISODODECANE, TRIMETHYLSILOXYSILICATE, PEG-6, PEG-32, SAXIFRAGA SARMENTOSA EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ONONIS SPINOSA ROOT EXTRACT, ECTOIN, SOPHORA ANGUSTIFOLIA ROOT EXTRACT, HYDROGEN DIMETHICONE, SILICA, CARBOXYDECYL TRISILOXANE, TRISODIUM EDTA, SODIUM ACRYLOYLDIMETHYLTAURATE/METHACRYLAMIDOLAURIC ACID COPOLYMER, ALUMINA, POLYMETHYLSILSESQUIOXANE, TALC, ALCOHOL, TRIETHOXYCAPRYLYLSILANE, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE,

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 DIST. NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

SHI SEIDO

Anti-Aging Suncare

50+

Ultimate
Sun Protection
Cream+

BROAD SPECTRUM
SPF 50+

For Face

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

50mL NET WT. 2.1 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO ULTIMATE SUN PROTECTION PLUS 
octinoxate, octocrylene, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-273
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4503 g  in 60.85 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1826 g  in 60.85 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1034 mg  in 60.85 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.74 g  in 60.85 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ONONIS CAMPESTRIS ROOT (UNII: FD2FMC53M1)
ECTOINE (UNII: 7GXZ3858RY)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TALC (UNII: 7SEV7J4R1U)
ALCOHOL (UNII: 3K9958V90M)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-273-60	1 in 1 CARTON	10/01/2012
1		60.85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2012

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(52686-273) , analysis(52686-273)