SHISEIDO GLOW ENHANCING PRIMER- avobenzone, octinoxate, octocrylene, and oxybenzone cream

SHISEIDO GLOW ENHANCING PRIMER by

Drug Labeling and Warnings

SHISEIDO GLOW ENHANCING PRIMER 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 3.0%	Sunscreen
OXYBENZONE 1.0%	Sunscreen

Uses

• helps prevent sunburn

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

WATERCETYL ETHYLHEXANOATEGLYCERINBUTYLENE GLYCOLCELLULOSEDIMETHICONEPEG-8SD ALCOHOL 40-BCAPRYLYL METHICONEDIPROPYLENE GLYCOLPEG-60 HYDROGENATED CASTOR OILPEG/PPG-36/41 DIMETHYL ETHERXANTHAN GUMGLYCYL GLYCINEPAEONIA ALBIFLORA ROOT EXTRACTZINGIBER AROMATICUS EXTRACTPPG-17BARIUM SULFATETRIETHANOLAMINECARBOMERALCOHOLACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMERSODIUM METAPHOSPHATEDIPENTAERYTHRITYL HEXAHYDROXYSTEARATEBHTALUMINASODIUM METABISULFITETOCOPHEROLBENZOIC ACIDFRAGRANCEMICATITANIUM DIOXIDEIRON 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 - 30 mL Tube Carton

SHISEIDO

Glow Enhancing
Primer

Smoothes on for
a vibrant finish.
Oil-free.

BROAD SPECTRUM
SPF 15
sunscreen

30mL NET WT. 1 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO GLOW ENHANCING PRIMER 
avobenzone, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-239
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	773 mg  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2287 mg  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	927 mg  in 30 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	309 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
XANTHAN GUM (UNII: TTV12P4NEE)
DIGLYCINE (UNII: 10525P22U0)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PPG-17 (UNII: OV0Q322E0U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
TROLAMINE (UNII: 9O3K93S3TK)
ALCOHOL (UNII: 3K9958V90M)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BENZOIC ACID (UNII: 8SKN0B0MIM)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-239-60	1 in 1 CARTON	02/01/2015
1		30 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 not final	part352	02/01/2015

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-239) , analysis(58411-239)