SHISEIDO ESSENTIAL ENERGY DAY- avobenzone, homosalate, octinoxate, octocrylene, and oxybenzone cream 
SHISEIDO AMERICAS CORPORATION

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.

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SHISEIDO ESSENTIAL ENERGY DAY CREAM

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.0%Sunscreen
HOMOSALATE 5.0%Sunscreen
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
OXYBENZONE 1.5%Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

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?

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PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

SHI SEIDO
GINZA TOKYO

Essential Energy
Day Cream

BROAD SPECTRUM
SPF 20
SUNSCREEN

ReNeura Technology™

50mL NET WT. 1.7 OZ.

Principal Display Panel - 50 mL Jar Carton
SHISEIDO ESSENTIAL ENERGY DAY 
avobenzone, homosalate, octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-364
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1020 mg  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2550 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3773 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1530 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE765 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-364-501 in 1 CARTON02/01/2018
150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2018
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-364) , analysis(58411-364)

Revised: 12/2018
Document Id: 7cf2da9e-b020-d215-e053-2a91aa0a549e
Set id: 039faa59-36f8-47b6-8c9b-f57d77205efd
Version: 2
Effective Time: 20181213
 
SHISEIDO AMERICAS CORPORATION