GM COLLIN SPF 60 MINERAL SUNSCREEN- titanium dioxide and zinc oxide cream

GM Collin SPF 60 Mineral Sunscreen by

Drug Labeling and Warnings

GM Collin SPF 60 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Laboratoires dermo Cosmetik, Product Quest MFG. LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide 4.9%
Zinc Oxide 4.7%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product avoid contact with 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 15 minutes before sun exposure.
• Reapply
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• Children under 6 months: Ask a doctor.
  Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. – 2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Alumina, Arachidyl Alcohol, Arachidyl Glucoside, Ascorbic Acid, Avena Sativa (Oat) Kernel Extract, Beeswax, Behenyl Alcohol, Benzyl Alcohol, BHT, Bisabolol, Butylene Glycol, Butyloctyl Salicylate, Cetyl Dimethicone, Dimethicone, Dimethicone PEG-8 Laurate, Dipotassium Glycyrrhizate, Disodium EDTA, Ehtylhexylglycerin, Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate / Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Methicone, Methylisothiazolinone, Pantothenic Acid, PEG-100 Stearate, PEG 8, Polyaminopropyl Biguanide, Polyhydroxystearic Acid, Polymethyl Methacrylate, Polysorbate 60, Potassium Sorbate, Retinyl Palmitate, Silica, Stearic Acid, Styrene / Acrylates Copolymer, Tocopheryl Acetate, Triethoxycaprylysilane, Trimethylsiloxysilicate, Trisiloxane, Water/eau, Xanthan Gum.

Questions?

USA: 1 (800) 341-1531 / CANADA: 1 (800) 361-1263

SPL UNCLASSIFIED SECTION

Distributed by:
® LABORATOIRES DERMO-COSMETIK INC.
68 STINSON, MONTREAL, QUEBEC, CANADA H4N 2E7

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

PARIS
COLLIN®
G.M.

60

MINERAL
SUNSCREEN

SUN PROTECTION CREAM
BROAD SPECTRUM SPF 60

(40 minutes)
Water Resistant

NDC: 64127-184-01
NPN xxxxxxxx

50 g - Net wt. 1.8 oz.

INGREDIENTS AND APPEARANCE

GM COLLIN SPF 60 MINERAL SUNSCREEN 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64127-184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	49 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	47 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
OAT (UNII: Z6J799EAJK)
YELLOW WAX (UNII: 2ZA36H0S2V)
DOCOSANOL (UNII: 9G1OE216XY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOHEXADECANE (UNII: 918X1OUF1E)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PANTOTHENIC ACID (UNII: 19F5HK2737)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLIHEXANIDE (UNII: 322U039GMF)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRISILOXANE (UNII: 9G1ZW13R0G)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64127-184-01	1 in 1 CARTON	06/01/2016
1		50 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 NOT FINAL	part352	06/01/2016

Labeler - Laboratoires dermo Cosmetik (249335480)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest MFG. LLC		927768135	MANUFACTURE(64127-184)