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

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 useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif 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:

• spray liberally and spread evenly by hand 15 minutes before sun exposure
• hold container 4 to 6 inches from the skin to apply.
• do not spray directly into face. Spray on hands then apply to face.
• do not apply in windy conditions.
• use in a well-ventilated area.
• 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

ALCOHOL DENAT.DIISOPROPYL SEBACATETRIETHYLHEXANOINC12-15 ALKYL BENZOATEDIMETHICONECAPRYLYL METHICONESILICA DIMETHYL SILYLATEDIPROPYLENE GLYCOLPPG-3 DIPIVALATEVITIS VINIFERA (GRAPE) SEED OILPEG/PPG-14/7 DIMETHYL ETHERLECITHINGLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACTPPG-17HYDROXYSTEARIC ACIDPOLYHYDROXYSTEARIC ACIDPOLYAMIDE-8PALMITIC ACIDLAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEBHTTOCOPHEROLPENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATEPHENOXYETHANOLFRAGRANCE

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 Cartridge Carton

SHISEIDO
GINZA TOKYO

Ultimate Sun Protector
Spray

SPF
40

Invisible and breathable
protection veil.

BROAD SPECTRUM
SPF 40

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

150mL 5 FL. OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-891
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.1533 g  in 150 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13.71 g  in 150 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	6.855 g  in 150 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6.855 g  in 150 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PPG-17 (UNII: OV0Q322E0U)
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
PALMITIC ACID (UNII: 2V16EO95H1)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-891-20	150 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	03/01/2024

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)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	analysis(58411-891) , manufacture(58411-891)