VITALUMIERE AQUA SPF 15: Package Insert and Label Information

VITALUMIERE AQUA SPF 15- octinoxate and titanium dioxide liquid
CHANEL PARFUMS BEAUTE

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT(S)

OCTINOXATE 6%

TITANIUM DIOXIDE 5.6%

WARNINGS

FOR EXTERNAL USE ONLY. NOT TO BE SWALLOWED. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR. IF IRRITATION PERSISTS, CONSULT A DOCTOR. KEEP OUT OF REACH OF CHILDREN. DO NOT USE ON INFANTS UNDER THE AGE OF SIX MONTHS.

DIRECTIONS FOR USE

APPLY WITH FINGERTIPS OR FOUNDATION BRUSH AND BLEND GENTLY.

INACTIVE INGREDIENTS

AQUA (WATER), METHYL TRIMETHICONE, ALCOHOL, DIMETHICONE, PHENYL TRIMETHICONE, TALC, BUTYLENE GLYCOL, ISODODECANE, POLYMETHYLSILSESQUIOXANE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, POLYMETHYL METHACRYLATE, PEG-10 DIMETHICONE, STEARIC ACID, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINA, ALUMINUM HYDROXIDE, PHENOXYETHANOL, C9-15 FLUOROALCOHOL PHOSPHATE, MAGNESIUM SULFATE, PARFUM (FRAGRANCE), NELUMBO NUCIFERA FLOWER WATER, METHYLPARABEN, TRIETHOXYCAPRYLYLSILANE, SODIUM HYALURONATE, SILICA, TOCOPHERYL ACETATE, DIPROPYLENE GLYCOL, POLYURETHANE-15, BHT, LAMINARIA DIGITATA EXTRACT, TOCOPHEROL, PROPYLPARABEN, ETHYLPARABEN [+/-(MAY CONTAIN) CI 77007 (ULTRAMARINES), CI 77491, CI77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE), MICA]

PRINCIPAL DISPLAY PANEL

VITALUMIERE AQUA

ULTRA-LIGHT

SKIN PERFECTING MAKEUP

INSTANT NATURAL RADIANCE

SPF 15

(SHADE)

CHANEL

30 ML 1 FL.OZ.

IMAGE OF CARTON
(click image for full-size original)
VITALUMIERE AQUA SPF 15
ultra-light skin perfecting makeup liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-1152
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.8 mL in 30 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.68 mL in 30 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68745-1152-2 1 BOTTLE, GLASS (BOTTLE) in 1 CARTON contains a BOTTLE, GLASS (68745-1152-1)
1 NDC:68745-1152-1 30 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (68745-1152-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/01/2011
Labeler — CHANEL PARFUMS BEAUTE (275137669)
Establishment
Name Address ID/FEI Operations
CHANEL PARFUMS BEAUTE 277032509 manufacture

Revised: 08/2010 CHANEL PARFUMS BEAUTE

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