Label: SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR- octinoxate, octocrylene, and zinc oxide lotion
- NDC Code(s): 58411-346-10, 58411-346-11, 58411-346-80
- Packager: SHISEIDO AMERICA INC.
- 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
- reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- 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, DIMETHICONE, ISODODECANE, SD ALCOHOL 40-B, DIPROPYLENE GLYCOL, ETHYLHEXYL PALMITATE, PEG-10 DIMETHICONE, GLYCERIN, POLYMETHYLSILSESQUIOXANE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, XYLITOL, 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, ALUMINA, BHT, TRIETHOXYCAPRYLYLSILANE, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, BENZOIC ACID, FRAGRANCE, TITANIUM DIOXIDE, MICA,
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR
octinoxate, octocrylene, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-346 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1557 mg in 31.77 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 953 mg in 31.77 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3971 mg in 31.77 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) DIPROPYLENE GLYCOL (UNII: E107L85C40) ETHYLHEXYL PALMITATE (UNII: 2865993309) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) XYLITOL (UNII: VCQ006KQ1E) THIOTAURINE (UNII: NQZ2D7AO62) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) ONONIS SPINOSA ROOT (UNII: FD2FMC53M1) ECTOINE (UNII: 7GXZ3858RY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) TOCOPHEROL (UNII: R0ZB2556P8) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZOIC ACID (UNII: 8SKN0B0MIM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-346-10 1 in 1 CARTON 10/01/2012 1 31.77 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:58411-346-80 2.12 g in 1 POUCH; Type 0: Not a Combination Product 10/01/2012 3 NDC:58411-346-11 1 in 1 CARTON 10/01/2012 3 7.41 g in 1 BOTTLE, PLASTIC; 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 10/01/2012 Labeler - SHISEIDO AMERICA INC. (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(58411-346) , ANALYSIS(58411-346)
