SHISEIDO ULTIMATE SUN PROTECTION- avobenzone, octinoxate, octocrylene, and oxybenzone cream

SHISEIDO ULTIMATE SUN PROTECTION by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 5.0%	Sunscreen
OXYBENZONE 3.0%	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∙DIMETHICONE∙SD ALCOHOL 40-B∙TALC∙METHYL METHACRYLATE CROSSPOLYMER∙ISODODECANE∙CETYL ETHYLHEXANOATE∙DIISOPROPYL SEBACATE∙TRIETHYLHEXANOIN∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙GLYCERIN∙DEXTRIN PALMITATE∙SUCROSE TETRASTEARATE TRIACETATE∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙TRIMETHYLSILOXYSILICATE∙XYLITOL∙SILICA∙SODIUM CHLORIDE∙PEG/PPG-14/7 DIMETHYL ETHER∙SAXIFRAGA SARMENTOSA EXTRACT∙SOPHORA ANGUSTIFOLIA ROOT EXTRACT∙DISTEARDIMONIUM HECTORITE∙ISOSTEARIC ACID∙CALCIUM STEARATE∙TRISODIUM EDTA∙VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER∙ALCOHOL∙BHT∙BUTYLENE GLYCOL∙STEARIC ACID∙SODIUM METABISULFITE∙SYZYGIUM JAMBOS LEAF EXTRACT∙TOCOPHEROL∙POLYSILICONE-2∙METHYLPARABEN∙FRAGRANCE∙IRON OXIDES∙

Other information

• protect this product in this container from excessive heat and direct sun.
• avoid contact with clothing and other textiles-may stain.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

SHISEIDO
GINZA TOKYO

Ultimate
Sun Protection Lotion

50+

WetForce
Turns Invisible

BROAD SPECTRUM
SPF 50+

For Face/Body

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

50mL 1.6 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO ULTIMATE SUN PROTECTION 
avobenzone, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-359
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1288 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2524 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2575 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1545 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TALC (UNII: 7SEV7J4R1U)
ISODODECANE (UNII: A8289P68Y2)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
GLYCERIN (UNII: PDC6A3C0OX)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
XYLITOL (UNII: VCQ006KQ1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOSTEARIC ACID (UNII: X33R8U0062)
CALCIUM STEARATE (UNII: 776XM7047L)
EDETATE TRISODIUM (UNII: 420IP921MB)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-359-10	1 in 1 CARTON	02/01/2018
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 58411-359-11	1 in 1 CARTON	02/01/2018
2		100 mL in 1 BOTTLE, PLASTIC; 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	02/01/2018

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-359) , analysis(58411-359)