GM COLLIN SPF 25 UVA - UVB URBAN PROTECTION VEIL SUNSCREEN- zinc oxide and titanium dioxide cream

GM Collin by

Drug Labeling and Warnings

GM Collin by is a Otc medication manufactured, distributed, or labeled by Laboratoires dermo Cosmetik Inc, Dermolab Pharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Product Facts / Drug Facts

ACTIVE INGREDIENT

Active ingredients:	Purpose
Zinc Oxide 13.3%	Sunscreen
Titanium Dioxide 3.8%	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. Shake well before each use.

Do not useon damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs.

Keep out of reach of children.

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

Directions

Adults over 18 years old:

• apply liberally 15 minutes before sun exposure.
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.
  To decrease 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.
• keep at room temperature (15 - 30°C / 59 - 86°F)

Inactive ingredients

1,2-HEXANEDIOL, ALUMINA, AQUA/WATER/EAU, ARGANIA SPINOSA KERNEL OIL, ASCORBYL PALMITATE, BISABOLOL, C12-15 ALKYL BENZOATE, FARNESOL, FRAGRANCE/PARFUM, HYDROGEN DIMETHICONE, ISODECYL LAURATE, MAGNESIUM SULFATE, NEOPENTYL GLYCOL DIETHYLHEXANOATE, PHENOXYETHANOL, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, POLYGLYCERYL-6 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, POTASSIUM SORBATE, PROPANEDIOL DICAPRYLATE, TOCOPHEROL, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE.

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 - 100 ml Bottle Box

G.M. COLLIN ®

C

SPF
25
UVA∙UVB

URBAN PROTECTION VEIL

Broad Spectrum
Mineral Sunscreen

NDC: 64127-234-01
NPN 801xxxxx
06886

100 ml - 3.4 fl. oz.

INGREDIENTS AND APPEARANCE

GM COLLIN  SPF 25 UVA - UVB URBAN PROTECTION VEIL SUNSCREEN
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64127-234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.6 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALUMINUM OXIDE (UNII: LMI26O6933)
WATER (UNII: 059QF0KO0R)
ARGAN OIL (UNII: 4V59G5UW9X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
LEVOMENOL (UNII: 24WE03BX2T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
FARNESOL (UNII: EB41QIU6JL)
ISODECYL LAURATE (UNII: 254BX4O0JU)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANEDIOL DICAPRYLATE (UNII: C577OMC6UH)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64127-234-01	1 in 1 BOX	01/15/2021
1		100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/15/2021

Labeler - Laboratoires Dermo-Cosmetik Inc. (249335480)

Establishment
Name	Address	ID/FEI	Business Operations
Dermolab Pharma Ltd		245414743	manufacture(64127-234)