SHISEIDO ULTIMATE SUN PROTECTOR- avobenzone, homosalate, octisalate, and octocrylene lotion

SHISEIDO ULTIMATE SUN PROTECTOR by

Drug Labeling and Warnings

SHISEIDO ULTIMATE SUN PROTECTOR 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 2.3%	Sunscreen
HOMOSALATE 10.0%	Sunscreen
OCTISALATE 5.0%	Sunscreen
OCTOCRYLENE 5.0%	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.

Flammable

Do not use near heat, flame, or while smoking

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･DIISOPROPYL SEBACATE･TALC･TRIETHYLHEXANOIN･DIMETHICONE･PEG/PPG-9/2 DIMETHYL ETHER･ALCOHOL DENAT.･LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE･GLYCERIN･DEXTRIN PALMITATE･SUCROSE TETRASTEARATE TRIACETATE･ISODODECANE･PPG-3 DIPIVALATE･TRIMETHYLSILOXYSILICATE･SILICA･DISTEARDIMONIUM HECTORITE･HYDROGENATED POLYISOBUTENE･SODIUM CHLORIDE･DIPOTASSIUM GLYCYRRHIZATE･AMINOETHANESULFINIC ACID･PEG/PPG-14/7 DIMETHYL ETHER･SAXIFRAGA SARMENTOSA EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･EUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACT･SOPHORA ANGUSTIFOLIA ROOT EXTRACT･SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACT･PPG-17･PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE･CALCIUM STEARATE･ISOSTEARIC ACID･PALMITIC ACID･TRISODIUM EDTA･ALCOHOL･SILICA DIMETHYL SILYLATE･PEG-6･BHT･TOCOPHEROL･BUTYLENE GLYCOL･STEARIC ACID･SODIUM METABISULFITE･POLYGLYCERYL-6 POLYRICINOLEATE･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･SYZYGIUM JAMBOS LEAF EXTRACT･PHENOXYETHANOL･FRAGRANCE･RED 33･YELLOW 5･

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 150 mL Container Carton

SHISEIDO
GINZA TOKYO

Ultimate Sun Protector
Lotion

SPF
60+

Invisible and breathable protection veil
strengthened by heat and water.

BROAD SPECTRUM
SPF 60+

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

150mL 5 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO ULTIMATE SUN PROTECTOR 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-888
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.67425 g  in 150 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.9875 g  in 150 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	7.9875 g  in 150 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.9875 g  in 150 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-9/2 DIMETHYL ETHER (UNII: LM6Q66468X)
ALCOHOL (UNII: 3K9958V90M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
GLYCERIN (UNII: PDC6A3C0OX)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
ISODODECANE (UNII: A8289P68Y2)
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PPG-17 (UNII: OV0Q322E0U)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
CALCIUM STEARATE (UNII: 776XM7047L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOSTEARIC ACID (UNII: X33R8U0062)
PALMITIC ACID (UNII: 2V16EO95H1)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
STEARIC ACID (UNII: 4ELV7Z65AP)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-888-40	1 in 1 CARTON	03/01/2024
1		150 mL in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 58411-888-41	1 in 1 CARTON	03/01/2024
2		50 mL in 1 CONTAINER; Type 0: Not a Combination Product
3	NDC: 58411-888-42	1 in 1 CARTON	03/01/2024
3		300 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	03/01/2024

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Registrant - Shiseido America Inc. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	ANALYSIS(58411-888) , MANUFACTURE(58411-888)