LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM MEDIUM 7- octinoxate, titanium dioxide emulsion

LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM MEDIUM 7 by

Drug Labeling and Warnings

LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM MEDIUM 7 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]

ACTIVE INGREDIENT

Active Ingredients Purpose

Octinoxate 7.00% Sunscreen

Titanium Dioxide 2.44% Sunscreen

PURPOSE

Uses

Helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

Warnings

Skin Cancer / Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. this product has 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.

DOSAGE & ADMINISTRATION

Directions

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

OTHER SAFETY INFORMATION

Other Information

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

INACTIVE INGREDIENT

Inactive ingredients:
WATER, CYCLOPENTASILOXANE, POLYMETHYL METHACRYLATE, CYCLOHEXASILOXANE, TRIMETHYLSILOXYSILICATE, PEG-10 DIMETHICONE, GLYCERIN, SODIUM CHLORIDE, PEG/PPG-18/18 DIMETHICONE, HYDROXYACETOPHENONE, PHENOXYETHANOL, COFFEA ARABICA (COFFEE) SEEDCAKE EXTRACT, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, SILICA DIMETHYL SILYLATE, ALUMINA, HEXYL LAURATE, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, CHLORPHENESIN, HYDROGEN DIMETHICONE, BHT, CARBOMER, POLYSORBATE 20, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7. MAY CONTAIN : TITANIUM DIOXIDE, IRON OXIDES, TRIETHOXYCAPRYLYLSILANE.

PRINCIPAL DISPLAY PANEL

L'BEL
EFFET PARFAIT
Signs of age appearance minimizer foundation SPF 20 FM

1.01 fl. oz. (30 ml)

MEDIUM 7

INGREDIENTS AND APPEARANCE

LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM MEDIUM 7 
octinoxate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-292
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.44 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-292-01	30 mL in 1 BOX; Type 0: Not a Combination Product	07/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/30/2021

Labeler - Ventura International LTD (603192787)

Registrant - Bel Star S.A. (Colombia) (880160197)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	manufacture(14783-292)