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

SHISEIDO ESSENTIAL ENERGY DAY by

Drug Labeling and Warnings

SHISEIDO ESSENTIAL ENERGY DAY by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

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:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• 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

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

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

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.

INGREDIENTS AND APPEARANCE

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

Product 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)