Label: SHISEIDO URBAN ENVIRONMENT OIL-FREE SUNSCREEN SPF 42- ensulizole, homosalate, octisalate, and zinc oxide emulsion
- NDC Code(s): 58411-670-10
- 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
- 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▪TRISILOXANE▪SD ALCOHOL 40-B▪ZINC OXIDE▪GLYCERIN▪SILICA▪PEG/PPG-14/7 DIMETHYL ETHER▪LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪PEG-10 DIMETHICONE▪TREHALOSE▪MYRISTYL MYRISTATE▪ETHYLHEXYL PALMITATE▪DEXTRIN PALMITATE▪ISODECYL NEOPENTANOATE▪ASCORBYL TETRAISOPALMITATE▪THIOTAURINE▪DIPOTASSIUM GLYCYRRHIZATE▪SCUTELLARIA BAICALENSIS ROOT EXTRACT▪PAEONIA ALBIFLORA ROOT EXTRACT▪SODIUM HYALURONATE▪SANGUISORBA OFFICINALIS ROOT EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪GARCINIA MANGOSTANA BARK EXTRACT▪PERILLA OCYMOIDES LEAF EXTRACT▪SPIRULINA PLATENSIS EXTRACT▪TRIETHANOLAMINE▪TRIETHOXYCAPRYLYLSILANE▪BUTYLENE GLYCOL▪DISODIUM EDTA▪DISTEARDIMONIUM HECTORITE▪TOCOPHEROL▪BHT▪ALCOHOL▪ISOSTEARIC ACID▪MENTHOXYPROPANEDIOL▪SODIUM METABISULFITE▪POLYSILICONE-2▪BARIUM SULFATE▪SODIUM CITRATE▪PHENOXYETHANOL▪BENZOIC ACID▪FRAGRANCE▪IRON OXIDES ▪
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO URBAN ENVIRONMENT OIL-FREE SUNSCREEN SPF 42
ensulizole, homosalate, octisalate, and zinc oxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-670 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 0.4 g in 30 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.4 g in 30 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.8 g in 30 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.6 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRISILOXANE (UNII: 9G1ZW13R0G) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TREHALOSE (UNII: B8WCK70T7I) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) ETHYLHEXYL PALMITATE (UNII: 2865993309) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) THIOTAURINE (UNII: NQZ2D7AO62) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) TROLAMINE (UNII: 9O3K93S3TK) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EDETATE DISODIUM (UNII: 7FLD91C86K) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) ISOSTEARIC ACID (UNII: X33R8U0062) 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) SODIUM METABISULFITE (UNII: 4VON5FNS3C) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-670-10 1 in 1 CARTON 01/01/2022 1 30 mL in 1 BOTTLE; 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)
