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

SHISEIDO IBUKI PROTECTIVE MOISTURIZER by

Drug Labeling and Warnings

SHISEIDO IBUKI PROTECTIVE MOISTURIZER 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 2.5%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 2.0%	Sunscreen
OXYBENZONE 1.0%	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.

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, 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

• 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 - 75 mL Bottle Carton

SHI SEIDO

IBUKI

Protective Moisturizer

BROAD SPECTRUM
SPF 18

SUNSCREEN

75mL 2.5 FL. OZ.

INGREDIENTS AND APPEARANCE

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

Product 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)