Manicure By Opi - Finishing Butter (Octinoxate, Oxybenzone) Cream [Opi Products, Inc] -

MANICURE BY OPI - FINISHING BUTTER (OCTINOXATE, OXYBENZONE) CREAM [OPI PRODUCTS, INC]
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NDC	61852-977-32
Set ID	69cad17b-d2c4-4a28-9a71-10147aeb46b3
Category	HUMAN OTC DRUG LABEL
Packager	OPI Products, Inc
Generic Name
Product Class
Product Number
Application Number	PART352

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - OPI Products, Inc (103062204)

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

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Medic

MANICURE BY OPI - FINISHING BUTTER (OCTINOXATE, OXYBENZONE) CREAM [OPI PRODUCTS, INC]

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