Label: SHISEIDO IBUKI PROTECTIVE MOISTURIZER- avobenzone, octinoxate, octocrylene, and oxybenzone emulsion
- NDC Code(s): 58411-101-10
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 13, 2018
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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 2 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, 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
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- PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO IBUKI PROTECTIVE MOISTURIZER
avobenzone, octinoxate, octocrylene, and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1903 mg in 76.12 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5633 mg in 76.12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1522 mg in 76.12 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 761 mg in 76.12 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-101-10 1 in 1 CARTON 08/01/2013 1 76.12 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-101) , analysis(58411-101)
