SHISEIDO ULTIMATE SUN PROTECTOR CLEAR- avobenzone, homosalate, octisalate, octocrylene stick

SHISEIDO ULTIMATE SUN PROTECTOR CLEAR by

Drug Labeling and Warnings

SHISEIDO ULTIMATE SUN PROTECTOR CLEAR 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

PURPOSE

Active Ingredients		Purpose
AVOBENZONE 2.5%	HOMOSALATE 11%	Sunscreen
OCTISALATE 5%	OCTOCRYLENE 9%

Uses

• helps prevent sunburn

Warnings

For external use only

DO NOT USE

Do not useon damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctorif rash occurs

KEEP OUT OF REACH OF CHILDREN

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. - 2p.m.
• wear long-sleeve shirts, pant, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Diphenylsiloxy Phenyl Trimethicone･Mineral Oil･Hydroxystearic Acid･Triethylhexanoin･PEG/PPG-9/2 Dimethyl Ether･Methyl Methacrylate Crosspolymer･Dibutyl Lauroyl Glutamide･C12-15 Alkyl Benzoate･Polyamide-8･Silica Dimethyl Silylate･Argania Spinosa Kernel Oil･Stearyl Glycyrrhetinate･Tocopheryl Acetate･PEG/PPG-14/7 Dimethyl Ether･Lecithin･Glycyrrhiza Glabra (Licorice) Root Extract･PPG-17･Castor Oil/IPDI Copolymer･Caprylic/Capric Triglyceride･BHT･Simethicone･PEG-6･Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate･Silica･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

PRINCIPLE DISPLAY PANNEL 20g OTHER

SHISEIDO'

GINZA TOKYO

Ultimate Sun Protector

Clear Stick

SPF 60+

Advanced Protection & Age Defense

BROAD SPECTRUM SPF 60+

WATER RESISTANT (80 MINUTES)

SUNSCREEN

20g NET WT..7 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO ULTIMATE SUN PROTECTOR CLEAR 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-969
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.5 g  in 19.98 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.2 g  in 19.98 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	1 g  in 19.98 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.8 g  in 19.98 mL

Inactive Ingredients
Ingredient Name	Strength
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
MINERAL OIL (UNII: T5L8T28FGP)
HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-9/2 DIMETHYL ETHER (UNII: LM6Q66468X)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H)
PPG-17 (UNII: OV0Q322E0U)
CASTOR OIL/IPDI COPOLYMER (UNII: GSA2TXZ34G)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BHT (UNII: 1P9D0Z171K)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
PEG-6 (UNII: 5655G9Y8AQ)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
SILICA (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-969-90	1 in 1 BOX	09/01/2025
1		20 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 58411-969-91	1 in 1 BOX	09/01/2025
2		60 mL in 1 PACKAGE; 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	09/01/2025

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-969) , analysis(58411-969)