Label: SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42- avobenzone, homosalate, octisalate, and octocrylene cream
- NDC Code(s): 58411-671-60
- 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 November 15, 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
- 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 un 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▪BUTYLENE GLYCOL▪GLYCERIN▪CAPRYLYL METHICONE▪SILICA▪DIPROPYLENE GLYCOL▪GLYCERYL DIISOSTEARATE▪SD ALCOHOL 40-B▪PEG/PPG-14/7 DIMETHYL ETHER▪BEHENETH-20▪BEHENYL ALCOHOL▪C30-45 ALKYL METHICONE▪TREHALOSE▪AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER▪XANTHAN GUM▪ASCORBYL TETRAISOPALMITATE▪DIPOTASSIUM GLYCYRRHIZATE▪SODIUM HYALURONATE▪SANGUISORBA OFFICINALIS ROOT EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪GARCINIA MANGOSTANA BARK EXTRACT▪PERILLA OCYMOIDES LEAF EXTRACT▪SPIRULINA PLATENSIS EXTRACT▪C30-45 OLEFIN▪BIS-PEG-18 METHYL ETHER DIMETHYL SILANE▪STEARYL ALCOHOL▪DISODIUM EDTA▪POTASSIUM HYDROXIDE▪BHT▪TOCOPHEROL▪CARBOMER▪ALCOHOL▪SODIUM METABISULFITE▪SYNTHETIC FLUORPHLOGOPITE▪SODIUM CITRATE▪PHENOXYETHANOL▪FRAGRANCE▪MICA▪TITANIUM DIOXIDE▪
- Other information
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- PRINCIPAL DISPLAY PANEL - 50mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42
avobenzone, homosalate, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-671 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.2 g in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.2 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.6 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.6 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) BEHENETH-20 (UNII: BJ4GP2IFLN) DOCOSANOL (UNII: 9G1OE216XY) C30-45 ALKYL METHICONE (UNII: NFX970DSI2) TREHALOSE (UNII: B8WCK70T7I) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) XANTHAN GUM (UNII: TTV12P4NEE) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) C30-45 OLEFIN (UNII: 6DWD51M0O8) BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ALCOHOL (UNII: 3K9958V90M) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-671-60 1 in 1 CARTON 01/01/2022 1 50 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 not final part352 01/01/2022 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
