Label: SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR- zinc oxide, homosalate, octocrylene, and octisalate emulsion
- NDC Code(s): 58411-627-60, 58411-627-61
- 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 January 12, 2021
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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 40 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
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive Ingredients
WATER∙ISODODECANE∙DIMETHICONE∙SD ALCOHOL 40-B∙DIPROPYLENE GLYCOL∙ETHYLHEXYL PALMITATE∙PEG-10 DIMETHICONE∙GLYCERIN∙POLYMETHYLSILSESQUIOXANE∙VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙XYLITOL∙SILICA∙METHYL METHACRYLATE CROSSPOLYMER∙THIOTAURINE∙SCUTELLARIA BAICALENSIS ROOT EXTRACT∙PAEONIA ALBIFLORA ROOT EXTRACT∙ONONIS SPINOSA ROOT EXTRACT∙ECTOIN∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙HYDROGEN DIMETHICONE∙BUTYLENE GLYCOL∙DISODIUM EDTA∙DISTEARDIMONIUM HECTORITE∙TOCOPHEROL∙ALUMINUM HYDROXIDE∙TRIETHOXYCAPRYLYLSILANE∙SODIUM METABISULFITE∙SYZYGIUM JAMBOS LEAF EXTRACT∙PHENOXYETHANOL∙BENZOIC ACID∙FRAGRANCE∙TITANIUM DIOXIDE∙MICA∙
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR
zinc oxide, homosalate, octocrylene, and octisalate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-627 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.16 g in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2.65 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.65 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.65 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYL PALMITATE (UNII: 2865993309) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) XYLITOL (UNII: VCQ006KQ1E) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EDETATE DISODIUM (UNII: 7FLD91C86K) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) THIOTAURINE (UNII: NQZ2D7AO62) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) MICA (UNII: V8A1AW0880) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) ECTOINE (UNII: 7GXZ3858RY) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) ONONIS SPINOSA ROOT (UNII: FD2FMC53M1) BENZOIC ACID (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-627-60 1 in 1 CARTON 01/01/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-627-61 1 in 1 CARTON 01/01/2021 2 30 mL in 1 TUBE; 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)
