LBEL LIBERTAGE CC MATTE PERFECTIONING-EFFECT MOISTURIZING FACE SPF 30- octinoxate and zinc oxide cream

LBEL LIBERTAGE CC MATTE PERFECTIONING-EFFECT MOISTURIZING FACE SPF 30 by

Drug Labeling and Warnings

LBEL LIBERTAGE CC MATTE PERFECTIONING-EFFECT MOISTURIZING FACE SPF 30 by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
OCTINOXATE 7 %	Sunscreen
ZINC OXIDE 6 %	Sunscreen

Uses

• Helps prevent sunburn.

Warnings

• Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

• 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

IISODODECANE, DIMETHICONE, WATER, POLYSILICONE-11, GLYCERIN, PEG-10 DIMETHICONE, ZEA MAYS (CORN) STARCH, TITANIUM DIOXIDE, HYDROXYETHYL UREA, IRON OXIDES, POLYMETHYLSILSESQUIOXANE, SODIUM PCA, PEG/PPG-18/18 DIMETHICONE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PHENOXYETHANOL, METHYLPROPANEDIOL, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, DISTEARDIMONIUM HECTORITE, PEG-8, CHLORPHENESIN, SILANEDIOL SALICYLATE, CERAMIDE 3, TRIETHOXYCAPRYLYLSILANE, TROMETHAMINE, LAURETH-12, BUTYLENE GLYCOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, PPG-1-PEG-9 LAURYL GLYCOL ETHER, HEDERA HELIX (IVY) LEAF/STEM EXTRACT, PHYTIC ACID, SODIUM POLYACRYLATE.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Int Ltd. DBA
Belcorp USA, Miami, FL 33126

PRINCIPAL DISPLAY PANEL - 35 g Tube Box

L'BEL
LIBERTÂGE

CC

CREAM
MATTE

matte perfectioning-effect
moisturizing face cream
SPF 30

color adapt

35 g e (Net wt. 1.23 oz.)

INGREDIENTS AND APPEARANCE

LBEL LIBERTAGE CC MATTE PERFECTIONING-EFFECT MOISTURIZING FACE SPF 30 
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.06 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
CERAMIDE NP (UNII: 4370DF050B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)
FYTIC ACID (UNII: 7IGF0S7R8I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-130-02	1 in 1 BOX	08/08/2018
1	NDC: 14783-130-01	35 g 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 FINAL	part352	08/08/2018

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-130)