SHISEIDO ESSENTIAL ENERGY HYDRATING DAY- homosalate, octocrylene, octisalate, and avobenzone emulsion

SHISEIDO ESSENTIAL ENERGY HYDRATING DAY by

Drug Labeling and Warnings

SHISEIDO ESSENTIAL ENERGY HYDRATING DAY by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. 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
OCTISALATE 5.0%	Sunscreen
OCTOCRYLENE 5.0%	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.

Flammable. Do not use near heat, flame. or while smoking

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every two 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 ∙ SD ALCOHOL 40-B ∙ DIMETHICONE ∙ GLYCERIN ∙ DIPROPYLENE GLYCOL ∙ ISODECYL NEOPENTANOATE ∙ PEG-20 ∙ AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER ∙ ERYTHRITOL ∙ PEG/PPG-14/7 DIMETHYL ETHER ∙ PEG/PPG-17/4 DIMETHYL ETHER ∙ LAURYL BETAINE ∙ XANTHAN GUM ∙ 2-O-ETHYL ASCORBIC ACID ∙ CAFFEINE ∙ PHYTOSTERYL MACADAMIATE ∙ SODIUM HYALURONATE ∙ CITRUS UNSHIU PEEL EXTRACT ∙ ANGELICA KEISKEI LEAF/STEM EXTRACT ∙ ZIZIPHUS JUJUBA FRUIT EXTRACT ∙ PANAX GINSENG ROOT EXTRACT ∙ SODIUM ACETYLATED HYALURONATE ∙ SCUTELLARIA BAICALENSIS ROOT EXTRACT ∙ SANGUISORBA OFFICINALIS ROOT EXTRACT ∙ PYROLA INCARNATA EXTRACT ∙ BEHENYL ALCOHOL ∙ SILICA ∙ DIGLYCERIN ∙ POLYSILICONE-11 ∙ BATYL ALCOHOL ∙ BUTYLENE GLYCOL ∙ BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 ∙ CARBOMER ∙ POTASSIUM HYDROXIDE ∙ PEG-60 GLYCERYL ISOSTEARATE ∙ ALCOHOL ∙ TOCOPHEROL ∙ BHT ∙ ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER ∙ SODIUM METABISULFITE ∙ ISOSTEARIC ACID ∙ DISODIUM EDTA ∙ SODIUM METAPHOSPHATE ∙ PPG-3 DIPIVALATE ∙ SYZYGIUM JAMBOS LEAF EXTRACT ∙ ALPINIA SPECIOSA LEAF EXTRACT ∙ ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT ∙ PHENOXYETHANOL ∙ SODIUM BENZOATE ∙ 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 Tube Carton

SHISEIDO
GINZA TOKYO

ESSENTIAL ENERGY

Hydrating Day Cream
BROAD SPECTRUM SPF 20
SUNSCREEN
ANTI-POLLUTION

Hyaluronic Acid RED

50mL NET WT. 1.7 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO ESSENTIAL ENERGY HYDRATING DAY 
homosalate, octocrylene, octisalate, and avobenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-656
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.53 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.53 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.53 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.012 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DOCOSANOL (UNII: 9G1OE216XY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIGLYCERIN (UNII: 3YC120743U)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
BATILOL (UNII: 39YR661C4U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
ERYTHRITOL (UNII: RA96B954X6)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
LAURYL BETAINE (UNII: Y4P927Q133)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CAFFEINE (UNII: 3G6A5W338E)
ISOSTEARIC ACID (UNII: X33R8U0062)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TANGERINE PEEL (UNII: JU3D414057)
ANGELICA KEISKEI TOP (UNII: AP628M4TQO)
JUJUBE FRUIT (UNII: G55HNL2C70)
ASIAN GINSENG (UNII: CUQ3A77YXI)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ROSEMARY (UNII: IJ67X351P9)
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-656-60	1 in 1 CARTON	05/01/2021
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 FINAL	part352	05/01/2021

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)