Label: SHISEIDO SUN PROTECTION EYE- octinoxate, octocrylene, and zinc oxide cream
- NDC Code(s): 58411-345-60, 58411-345-61, 58411-345-80
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 26, 2019
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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
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 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
WATER • ISOHEXADECANE • GLYCERIN • BUTYLENE GLYCOL • DIPROPYLENE GLYCOL • ISODODECANE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DISTEARDIMONIUM HECTORITE • POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER • TRIMETHYLSILOXYSILICATE • XYLITOL • METHYL GLUCETH-10 • DIMETHICONE • SD ALCOHOL 40-B • PEG/PPG-14/7 DIMETHYL ETHER • ZINC MYRISTATE • TOCOPHERYL ACETATE • DIPOTASSIUM GLYCYRRHIZATE • SCUTELLARIA BAICALENSIS ROOT EXTRACT • ONONIS SPINOSA ROOT EXTRACT • ECTOIN • SOPHORA ANGUSTIFOLIA ROOT EXTRACT • HYDROGEN DIMETHICONE • ISOSTEARIC ACID • TRISODIUM EDTA • ALCOHOL • ALUMINA • TRIETHOXYCAPRYLYLSILANE • BHT • TOCOPHEROL • SYZYGIUM JAMBOS LEAF EXTRACT • PHENOXYETHANOL • FRAGRANCE • TITANIUM DIOXIDE •
- Other information
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- PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO SUN PROTECTION EYE
octinoxate, octocrylene, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-345 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 479 mg in 16.5 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 495 mg in 16.5 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1749 mg in 16.5 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOHEXADECANE (UNII: 918X1OUF1E) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIPROPYLENE GLYCOL (UNII: E107L85C40) ISODODECANE (UNII: A8289P68Y2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) XYLITOL (UNII: VCQ006KQ1E) METHYL GLUCETH-10 (UNII: N0MWT4C7WH) DIMETHICONE (UNII: 92RU3N3Y1O) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) ZINC MYRISTATE (UNII: K09A9E2GGO) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ONONIS SPINOSA ROOT (UNII: FD2FMC53M1) ECTOINE (UNII: 7GXZ3858RY) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ISOSTEARIC ACID (UNII: X33R8U0062) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) ALUMINUM OXIDE (UNII: LMI26O6933) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-345-60 1 in 1 CARTON 12/01/2012 1 16.5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-345-61 1 in 1 CARTON 12/01/2012 2 NDC:58411-345-80 1.65 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/01/2012 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(58411-345) , ANALYSIS(58411-345)
