Label: SHISEIDO CLEAR SUNSCREEN SPF 50 PLUS- avobenzone, homosalate, octisalate, and octocrylene stick
- NDC Code(s): 58411-616-20
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 18, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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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
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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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 20 g Stick Pouch Label
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INGREDIENTS AND APPEARANCE
SHISEIDO CLEAR SUNSCREEN SPF 50 PLUS
avobenzone, homosalate, octisalate, and octocrylene stickProduct 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 FINAL part352 01/01/2021 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
