GM Collin® 50Plus DRY TOUCH SUN PROTECTION

Drug Labeling and Warnings

Drug Details [pdf]

GM COLLIN 50PLUS DRY TOUCH  SUN PROTECTION- avobenzone, homosalate, octisalate, and octocrylene cream 
Laboratoires dermo Cosmetik

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.

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GM Collin® 50Plus DRY TOUCH
SUN PROTECTION

Drug Facts

Active ingredients

Avobenzone 3.0%
Homosalate 15.0%
Octisalate 5.0%
Octocrylene 10.0%

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 80 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

Behenyl Alcohol, BHT, Butyloctyl Salicylate, Caprylyl Methicone, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Fragrance, Glyceryl Stearate, Hydrated Silica, PEG-100 Stearate, Phenoxyethanol, Polyester-8, Sodium Polyacrylate, Styrene/Acrylates Copolymer, Trideceth-6, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water/eau, Xanthan Gum.

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 100 g Tube Box

PARIS
G.M. COLLIN®

C

50+

DRY TOUCH

SUN PROTECTION CREAM
BROAD SPECTRUM SPF 50+

FACE & BODY

(80 minutes)
Water Resistant

NDC: 64127-204-01
DIN xxxxxx

100 g - Net wt. 3.5 oz.

Principal Display Panel - 100 g Tube Box
GM COLLIN 50PLUS DRY TOUCH   SUN PROTECTION
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64127-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate150 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Docosanol (UNII: 9G1OE216XY)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)  
Dimethicone (UNII: 92RU3N3Y1O)  
Dimethyl Capramide (UNII: O29Y6X2JEZ)  
Edetate Disodium (UNII: 7FLD91C86K)  
Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
PEG-100 Stearate (UNII: YD01N1999R)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Polyester-8 (1400 MW, Cyanodiphenylpropenoyl Capped) (UNII: T9296U138P)  
Trideceth-6 (UNII: 3T5PCR2H0C)  
Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64127-204-011 in 1 BOX06/01/201607/31/2019
1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/201607/31/2019
Labeler - Laboratoires dermo Cosmetik (249335480)

Revised: 10/2019
Document Id: 42a1eeb8-30ed-4f98-9e12-721788acd41d
Set id: e89d88d1-0796-44ce-b041-87fb99c66a49
Version: 2
Effective Time: 20191017