Label: SHISEIDO ESSENTIAL ENERGY HYDRATING DAY- homosalate, octocrylene, octisalate, and avobenzone emulsion
- NDC Code(s): 58411-656-60
- 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 March 26, 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
- use a water resistant sunscreen if swimming or sweating
- reapply at least every two 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 ∙ 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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO ESSENTIAL ENERGY HYDRATING DAY
homosalate, octocrylene, octisalate, and avobenzone emulsionProduct 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)
