SHISEIDO IBUKI PROTECTIVE MOISTURIZER- avobenzone, octinoxate, octocrylene, and oxybenzone emulsion 
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 IBUKI PROTECTIVE MOISTURIZER

Drug Facts

ACTIVE INGREDIENTS: Purpose
AVOBENZONE 2.5%Sunscreen
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 2.0%Sunscreen
OXYBENZONE 1.0%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, SD ALCOHOL 40-B, GLYCERIN, DIPROPYLENE GLYCOL, DIMETHICONE, ETHYLHEXYL PALMITATE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, SILICA, TREHALOSE, BETAINE, GLYCYL GLYCINE, LAURYL BETAINE, PAEONIA ALBIFLORA ROOT EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, LAMIUM ALBUM FLOWER EXTRACT, CITRUS JUNOS SEED EXTRACT, ZINGIBER AROMATICUS EXTRACT, PEG-20 GLYCERYL ISOSTEARATE, TRIISOSTEARIN, TRIETHANOLAMINE, ISOSTEARIC ACID, ALCOHOL, BUTYLENE GLYCOL, CARBOMER, BATYL ALCOHOL, BEHENYL ALCOHOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRISODIUM EDTA, SODIUM METABISULFITE, BHT, PHENOXYETHANOL, SODIUM BENZOATE, BENZOIC ACID, FRAGRANCE, TITANIUM DIOXIDE, MICA,

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

SHI SEIDO

IBUKI

Protective Moisturizer

BROAD SPECTRUM
SPF 18

SUNSCREEN

75mL 2.5 FL. OZ.

Principal Display Panel - 75 mL Bottle Carton
SHISEIDO IBUKI PROTECTIVE MOISTURIZER 
avobenzone, octinoxate, octocrylene, and oxybenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1903 mg  in 76.12 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5633 mg  in 76.12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1522 mg  in 76.12 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE761 mg  in 76.12 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TREHALOSE (UNII: B8WCK70T7I)  
BETAINE (UNII: 3SCV180C9W)  
DIGLYCINE (UNII: 10525P22U0)  
LAURYL BETAINE (UNII: Y4P927Q133)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
LAMIUM ALBUM FLOWER (UNII: 62IB9494JA)  
CITRUS JUNOS SEED (UNII: UY43O1Q45N)  
PEG-20 GLYCERYL ISOSTEARATE (UNII: ABV7KNA149)  
TRIISOSTEARIN (UNII: 71503RH8KG)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BATILOL (UNII: 39YR661C4U)  
DOCOSANOL (UNII: 9G1OE216XY)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-101-101 in 1 CARTON08/01/2013
176.12 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2013
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-101) , analysis(58411-101)

Revised: 12/2018
Document Id: 7cf0cb08-78a7-306c-e053-2a91aa0ae822
Set id: 17d47248-f03f-4dd9-b242-af7fcbd95761
Version: 2
Effective Time: 20181213
 
SHISEIDO AMERICAS CORPORATION