SHISEIDO CLEAR SUNSCREEN SPF 50 PLUS- avobenzone, homosalate, octisalate, and octocrylene stick

SHISEIDO CLEAR SUNSCREEN SPF 50 Plus by

Drug Labeling and Warnings

SHISEIDO CLEAR SUNSCREEN SPF 50 Plus by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
AVOBENZONE 2.5%	Sunscreen
HOMOSALATE 10.0%	Sunscreen
OCTISALATE 5.0%	Sunscreen
OCTOCRYLENE 10.0%	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 two 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

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▪TOCOPHERYL ACETATE▪PEG/PPG-14/7 DIMETHYL ETHER▪LECITHIN▪GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT▪PPG-17▪CASTOR OIL/IPDI COPOLYMER▪CAPRYLIC/CAPRIC TRIGLYCERIDE▪BHT▪TOCOPHEROL▪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

PRINCIPAL DISPLAY PANEL - 20 g Stick Pouch Label

SHISEIDO
GINZA TOKYO

Clear Sunscreen Stick
50+

SynchroShield
WetForce × HeatForce

BROAD SPECTRUM
SPF 50+
For Face/Body
WATER RESISTANT
(80 MINUTES)
SUNSCREEN

BIO

RE
USE

20g NET WT. .7 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO CLEAR SUNSCREEN SPF 50 PLUS 
avobenzone, homosalate, octisalate, and octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-616
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	500 mg  in 20 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2000 mg  in 20 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1000 mg  in 20 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2000 mg  in 20 g

Inactive Ingredients
Ingredient Name	Strength
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
MINERAL OIL (UNII: T5L8T28FGP)
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-9/2 DIMETHYL ETHER (UNII: LM6Q66468X)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PPG-17 (UNII: OV0Q322E0U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-616-20	1 in 1 POUCH	01/01/2021
1		20 g in 1 CARTRIDGE; 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	01/01/2021

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	ANALYSIS(58411-616) , MANUFACTURE(58411-616)