GM Collin Mineral Sun

Dosage form: lotion
Ingredients: Zinc oxide 0.039mL in 1mL, titanium dioxide 0.08mL in 1mL
Labeler: Laboratoires Dermo Cosmetik Inc.
NDC Code: 64127-074

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.

MINERAL
SUN CREAM

Drug Facts

Active ingredientPurpose
Zinc Oxide 3.9%Sunscreen
Titanium Dioxide 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.

  • Avoid contact with eyes.

  • Discontinue use if signs of irritation appear.

  • If irritation persists, consult a health care practitioner.

  • Do not use on infants under 6 months.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Directions
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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 10a.m.-2p.m.
    • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Apply evenly 15 to 30 minutes before sun exposure, massage until fully absorbed.
  • Reapply every 2 hours, after swimming, showering, toweling or heavy perspiration.

Inactive ingredients

CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, ISOHEXADECANE, TRIETHYLHEXANOIN, ALUMINIUM STEARATE, POLYHYDROXYSTEARIC ACID, ALUMINA, PEG/PPG-19/19 DIMETHICONE, DIMETHICONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONOL, WATER/EAU, BIS-HYDROXYETHOXYPROPYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, ISONONYL ISONONANOATE, LAURYL PEG/PPG-18/18 METHICONE, GLYCERIN, CASSIA ALATA (CANDLE TREE) LEAF EXTRACT, PHENOXYETHANOL, TOCOPHERYL ACETATE (VITAMIN E), ETHYLHEXYLGLYCERIN

Questions?

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

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

PARIS

G.M. COLLIN®

C

MINERAL
SUN CREAM

FPS 25 SPF

Broad Spectrum UVA-UVB
SUNSCREEN

NDC 64127-074-01

All Skin Types

50 ml - Net wt. 1.7 oz.

GM COLLIN MINERAL SUN 
zinc oxide and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64127-074
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc oxide (Zinc oxide) Zinc oxide0.039 mL  in 1 mL
titanium dioxide (titanium dioxide) titanium dioxide0.08 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
ISOHEXADECANE 
TRIETHYLHEXANOIN 
ALUMINUM STEARATE 
ALUMINUM OXIDE 
WATER 
TRIETHOXYCAPRYLYLSILANE 
ISONONYL ISONONANOATE 
GLYCERIN 
SENNA ALATA LEAF 
PHENOXYETHANOL 
.ALPHA.-TOCOPHEROL ACETATE 
ETHYLHEXYLGLYCERIN 
Packaging
#Item CodePackage Description
1NDC:64127-074-0150 mL in 1 TUBE
2NDC:64127-074-02150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/20/2011
Labeler - Laboratoires Dermo Cosmetik Inc. (249335480)
Establishment
NameAddressID/FEIOperations
Laboratoires Dermo Cosmetik, Inc.249335480MANUFACTURE

Revised: 05/2012
 
Laboratoires Dermo Cosmetik Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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