MANICURE BY OPI - FINISHING BUTTER- octinoxate, oxybenzone cream

MANICURE BY OPI - FINISHING BUTTER by

Drug Labeling and Warnings

MANICURE BY OPI - FINISHING BUTTER by is a Otc medication manufactured, distributed, or labeled by OPI Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts
Active ingredients . . . . . . . . . . . . . . . . .        Purpose
Octinoxate 7.5% . . . . . . . . . . . . . . . . . . . . . . . Sunscreen
Oxybenzone 3.5%. . . . . . . . . . . . . . . . . . . . . . Sunscreen

PURPOSE

Use
Helps prevent sunburn
Provides moderate protection against sunburn

WARNINGS

Warnings
For external use only
When using this product keep out of eyes. Rinse
with water to remove.
Stop use and ask a doctor if irritation develops and
lasts.

DOSAGE & ADMINISTRATION

Directions
Apply evenly before sun exposure and as needed.
Children under 6 months of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients Water/Aqua/Eau,
Cyclopentasiloxane, Caprylyl Methicone, Sucrose
Stearate, Dimethicone Crosspolymer, Glyceryl Stearate,
PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium
Acryloyldimethyl Taurate Copolymer, Squalane,
Polysorbate 60, Isopropylparaben, Isobutylparaben,
Butylparaben, Phenoxyethanol, Dehydroacetic Acid,
Salicylic Acid, Benzoic Acid, Benzethonium Chloride,
Benzyl Alcohol, Polysilicone-11, Ethylhexyl
Hydroxystearate, Xanthan Gum, Fragrance, Orange 4.

QUESTIONS

Questions or comments?
Call toll free Mon-Fri 1-800-341-9999

SPL UNCLASSIFIED SECTION

PRECAUTION: Tenir hors de portée des enfants. En cas
d’irritation, en cesser l’utilisation.
PRECAUCION: Mantener lejos del alcance de los niños. Si
hubiera irritación descontinuar su uso.

©2010 OPI Products Inc., N. Hollywood, CA 91605 818.759.2400
www.opi.com Ver. 10-0066 OPI Item No. MC 134 Made in USA
OPI Products Europe, 5708 JW, Helmond, Netherlands

PRINCIPAL DISPLAY PANEL

OPI

MANICURE by OPI

finishing
butter
skin massage and moisturizing butter.
beurre de massage hydratant pour la peau.
crema para hacer masajes e hidratar la
piel. hautmassage und feuchtigkeitskreme.
spf 15
950mL/32 Fl. Oz. e

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MANICURE BY OPI - FINISHING BUTTER 
octinoxate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61852-977
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
SQUALENE (UNII: 7QWM220FJH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
BENZYL ALCOHOL (UNII: LKG8494WBH)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61852-977-32	950 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/22/2010

Labeler - OPI Products, Inc (103062204)

Establishment
Name	Address	ID/FEI	Business Operations
OPI Products, Inc		103062204	manufacture