G.M. Collin Mineral Sun Veil: Package Insert and Label Information

G.M. COLLIN MINERAL SUN VEIL- zinc oxide cream
Laboratoires Dermo Cosmetik Inc.

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.

THE THREE-STEP SOLUTION

PhytoWhite™ Dark Spot Serum

This serum is specially formulated to visibly reduce the appearance of dark spots.

Caution: Do not apply the serum on entire face. Use of the PhytoWhite™ Serum may make your skin more sensitive to the sun. Apply G.M. Collin sun protection before sun exposure while using this product and for a week afterwards.

PhytoWhite™ Cream: This treating cream hydrates, nourishes, and brightens skin. The complexion becomes clearer and uniform.

Mineral Sun Veil Cream SPF 15: Formulated exclusively with Zinc Oxide, it offers a complete protection against sunburn and skin damage caused by both UVA and UVB exposure.

Caution: Keep out of reach of children. For external use only. Discontinue use if signs of irritation appear. Can be used alone and on children 6 months and older. Avoid contact with eyes.

Use: After the G.M. Collin cleanser and treating lotion, apply the serum on dark spots only. Apply the cream on the entire face and complete with Sun Protection SPF 15 +.

Frequency: Morning and evening or as recommended by your skincare professional.

Ref. GV1652

PHYTOWHITE™ DARK SPOT SERUM

Ref. GV1642

INGREDIENTS

WATER/EAU, SD ALCOHOL 3-A, BUTYLENE GLYCOL, GLYCOLIC ACID, ARGININE, POTASSIUM AZELOYL DIGLYCINATE, GLYCERIN, BRASSICA NAPUS EXTRACT, NIACINAMIDE, 1-METHYLHYDANTOINE-2-IMIDE, POLYSORBATE 20, ETHOXYDIGLYCOL, PHYLLANTHUS EMBLICA FRUIT EXTRACT, ERGOTHIONEINE, TETRAHYDRODIFERULOYLMETHANE, LICORICE EXTRACT, POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (VITAMIN C, VITAMIN E), ALLANTOIN, HYDROXYPROPYLCELLULOSE, TETRAHYDROPIPERINE, PEG-40 HYDROGENATED CASTOR OIL, DISODIUM EDTA, SODIUM METABISULFITE, FRAGRANCE/PARFUM

PHYTOWHITE™ CREAM

Ref. GV1651

INGREDIENTS

WATER/EAU, OLIGOPEPTIDE-34, ARACHIDYL ALCOHOL, BEHENYL ALCOHOL, ARACHIDYL GLUCOSIDE, NIACINAMIDE, BRASSICA NAPUS EXTRACT, PENTYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, SODIUM PCA, UREA, TREHALOSE, POLYQUATERNIUM-51, SODIUM HYALURONATE, LEPIDIUM SATIVUM SPROUT EXTRACT, PHENOXYETHANOL, LECITHIN, SOY ISOFLAVONES, POLYSORBATE 80 , ALCOHOL, SQUALANE (VEGETAL), PEG-8, CETEARYL ISONONANOATE, ASCORBYL GLUCOSIDE, PICHIA/RESVERATROL FERMENT EXTRACT, TOCOPHERYL ACETATE (VITAMIN E), ISOSTEARYL AVOCADATE, BUTYROSPERMUM PARKII (SHEA BUTTER), BIOSACCHARIDE GUM-1, DIPALMITOYL HYDROXYPROLINE, DIMETHICONE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE,CYCLOPENTASILOXAN E, CYCLOTETRASILOXANE, DIMETHICONOL, PEG-100 STEARATE, GLYCERYL STEARATE, ERGOTHIONEINE, ASCORBYL TETRA 2-HEXYLDECANOATE, XYLITYLGLUCOSIDE, ANHYDROXYLITOL, XYLITOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, SOYBEAN (GLYCINE SOYA), PANTHENOL, C12-15 ALKYL BENZOATE, TRIBEHENIN, CERAMIDE 2, PEG-10 RAPESEED STEROL, PALMITOYL OLIGOPEPTIDE, FRAGRANCE/PARFUM, CHLORPHENESIN, ETHYLHEXYLGLYCERIN, SODIUM METABISULFITE, DISODIUM EDTA, SODIUM HYDROXIDE, SODIUM CITRATE, TETRADIBUTYL PENTAERITHRITYL HYDROXYHYDROCINNAMATE, XANTHAN GUM, CITRIC ACID

15 SPF MINERAL SUN VEIL CREAM
NDC 64127-014-02

Ref. GV1725

ACTIVE INGREDIENTS

ZINC OXIDE 12.5%

INGREDIENTS

CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, POLYSILICONE-11, WATER/EAU, DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER, COPERNICIA CERIFERA (CARNAUBA) WAX, PPG-15 STEARYL ETHER, CETYL PEG/PPG-10/1 DIMETHICONE, GLYCERIN, BUTYLENE GLYCOL, CITRUS MEDICA LIMONIUM (LEMON) EXTRACT, FUMARIA OFFICINALIS EXTRACT, FUMARIC ACID, SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE, BUTETH-3, TRIBUTYL CITRATE, TRIS (TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE, ETHYLHEXYLGLYCERIN, CHLORPHENESIN, CASSIA ALATA (CANDLE TREE) LEAF EXTRACT, TOCOPHEROL (VITAMIN E)

MADE IN CANADA
® LABORATOIRES DERMO-COSMETIK INC.
68 STINSON, MONTREAL, QUEBEC, CANADA H4N 2E7

PRINCIPAL DISPLAY PANEL — Kit Carton

SYSTÈME ÉCLAIRCISSANT
PHYTOWHITE™
BRIGHTENING SYSTEM

Tous types de peau
All Skin Types

NDC 64127-084-01

SÉRUM
ANTI-TACHES
PHYTOWHITE™
DARK SPOT
SERUM
20 ml – 0.68 fl. oz.

CRÈME
PHYTOWHITE™
CREAM
50 ml – 1.7 fl. oz.

VOILE SOLAIRE
MINERAL
SUN VEIL
FPS 15 SPF50 ml – Net wt. 1.7 oz.

Principal Display Panel -- Kit Carton
(click image for full-size original)
G.M. COLLIN MINERAL SUN VEIL zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64127-084
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
zinc oxide (zinc oxide) zinc oxide 0.125 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5
CYCLOMETHICONE 6
WATER
CARNAUBA WAX
GLYCERIN
BUTYLENE GLYCOL
LEMON
FUMARIC ACID
ETHYLHEXYLGLYCERIN
CHLORPHENESIN
ALPHA-TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64127-084-01 1 TUBE (TUBE) in 1 KIT contains a TUBE
1 50 mL in 1 TUBE This package is contained within the KIT (64127-084-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 05/17/2010
Labeler — Laboratoires Dermo Cosmetik Inc. (249335480)
Establishment
Name Address ID/FEI Operations
Laboratoires Dermo Cosmetik Inc. 249335480 MANUFACTURE

Revised: 05/2010 Laboratoires Dermo Cosmetik Inc.

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