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

A luxurious, professional massage and finishing
butter. Envelops skin in a protective layer of silky
emollients to combat dryness. Protects against sun’s
harmful rays and helps prevent age spots from
returning when used with Manicure by OPI
Rejuvenating Serum. Apply before sun exposure and
as needed.

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

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

PRINCIPAL DISPLAY PANEL

A luxurious, professional massage and finishing butter. Envelops skin in a
protective layer of silky emollients to combat dryness. Protects against sun’s
harmful rays and helps prevent age spots from returning when used with
Manicure by OPI Rejuvenating Serum.

Un soin de massage professionnel de luxe, enrichi au beurre. Il enveloppe la
peau d’une couche protectrice composée d’émollients soyeux qui combattent
la sécheresse. Il protège contre les rayons néfastes du soleil, et le retour des
taches de vieillesse quand utilisé conjointement avec Manicure by OPI
Rejuvenating Serum.

Un lujoso masaje profesional y crema de terminación.Envuelve la piel con una
capa protectora de sedosos emolientes que combaten la sequedad. Protege
contra los dañinos rayos solares y ayuda a prevenir el retorno de las manchas
de la edad cuando se utiliza con Manicure por OPI Rejuvenating Serum.
Eine luxerioese, professionelle Massagen- und Feuchtigkeitskreme.

Seidene Weichmacher huellen die Haut gegen Trockenheit ein. Schuetzt die
Haut gegen schaedliche Sonnenstrahlen und vermindert "age spots" durch

Anwendung mit Manicure by OPI Rejuvenating Serum.

Active Ingredients: Octinoxate 7.5%, Oxybenzone 3.5%
Ingrédients Actifs: Octinoxate 7.5%, Oxybenzone 3.5%
Ingredientes Activos: Octinoxato 7.5%, Oxibenzona 3.5%
Aktive Inhaltsstoffe: Octinoxate 7.5%, Oxybenzone 3.5%

CAUTION: Keep out of reach of children. If irritation occurs, discontinue use.

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

VORSICHT: Von Kindern fernhalten. Gebrauch einstellen, falls
Irritationen auftreten sollten. Enthaelt Oxybenzone.

©2006 OPI Products Inc., N. Hollywood, CA 91605 818.759.2400
www.opi.com Ver. 06-1012 OPI Item No. MC 134
Made in USA OPI Products Europe, 5708 JW, Helmond, Netherlands

PRINCIPAL DISPLAY PANEL

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: 61852-978
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: 61852-978-04	1 in 1 BOX
1		120 mL in 1 BOTTLE
2	NDC: 61852-978-85	1 in 1 BOX
2		250 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