Label: SHISEIDO ESSENTIAL ENERGY DAY- avobenzone, homosalate, octinoxate, octocrylene, and oxybenzone cream
- NDC Code(s): 58411-364-50
- 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 December 13, 2018
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- Download DRUG LABEL INFO: PDF XML
- 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∙DIPROPYLENE GLYCOL∙BETAINE∙BUTYLENE GLYCOL∙GLYCERIN∙BEHENYL ALCOHOL∙SD ALCOHOL 40-B∙DIMETHICONE∙ISODODECANE∙ISOHEXADECANE∙BEHENETH-20∙SILICA∙MYRISTYL MYRISTATE∙PHYTOSTERYL MACADAMIATE∙ERYTHRITOL∙XANTHAN GUM∙TOCOPHERYL ACETATE∙PEG/PPG-14/7 DIMETHYL ETHER∙PEG/PPG-17/4 DIMETHYL ETHER∙CAFFEINE∙SCUTELLARIA BAICALENSIS ROOT EXTRACT∙ANGELICA KEISKEI LEAF/STEM EXTRACT∙SODIUM ACETYLATED HYALURONATE∙CAMELLIA SINENSIS LEAF EXTRACT∙CITRUS UNSHIU PEEL EXTRACT∙ZINGIBER AROMATICUS EXTRACT∙HYDROLYZED CONCHIOLIN PROTEIN∙POLYQUATERNIUM-51∙PYROLA INCARNATA EXTRACT∙PANAX GINSENG ROOT EXTRACT∙PPG-17∙STEARYL ALCOHOL∙BEHENETH-30∙ALCOHOL∙DISODIUM EDTA∙CARBOMER∙CELLULOSE GUM∙BHT∙SODIUM METAPHOSPHATE∙POTASSIUM HYDROXIDE∙SODIUM METABISULFITE∙TOCOPHEROL∙HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER∙CINNAMOMUM CASSIA BARK EXTRACT∙PHENOXYETHANOL∙FRAGRANCE∙IRON OXIDES∙
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO ESSENTIAL ENERGY DAY
avobenzone, homosalate, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-364 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1020 mg in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2550 mg in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3773 mg in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1530 mg in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 765 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) BETAINE (UNII: 3SCV180C9W) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) DOCOSANOL (UNII: 9G1OE216XY) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) ISOHEXADECANE (UNII: 918X1OUF1E) BEHENETH-20 (UNII: BJ4GP2IFLN) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ERYTHRITOL (UNII: RA96B954X6) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K) CAFFEINE (UNII: 3G6A5W338E) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ANGELICA KEISKEI TOP (UNII: AP628M4TQO) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GREEN TEA LEAF (UNII: W2ZU1RY8B0) TANGERINE PEEL (UNII: JU3D414057) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) ASIAN GINSENG (UNII: CUQ3A77YXI) PPG-17 (UNII: OV0Q322E0U) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) BEHENETH-30 (UNII: 21Z34J9KN8) ALCOHOL (UNII: 3K9958V90M) EDETATE DISODIUM (UNII: 7FLD91C86K) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SODIUM METABISULFITE (UNII: 4VON5FNS3C) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) CHINESE CINNAMON (UNII: WS4CQ062KM) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-364-50 1 in 1 CARTON 02/01/2018 1 50 mL in 1 JAR; 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 02/01/2018 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-364) , analysis(58411-364)
