MINERALSUN CREAM

Drug Labeling and Warnings

Drug Details [pdf]

GM COLLIN MINERAL SUN- zinc oxide and titanium dioxide lotion 
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.

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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.

Principal Display Panel - 50 ml Tube Carton
GM COLLIN MINERAL SUN 
zinc oxide and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64127-074
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide39 mg  in 1 mL
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP) titanium dioxide80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
WATER (UNII: 059QF0KO0R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64127-074-0150 mL in 1 TUBE; Type 0: Not a Combination Product04/20/201110/05/2015
2NDC: 64127-074-02150 mL in 1 TUBE; Type 0: Not a Combination Product04/20/201110/05/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/20/201110/05/2015
Labeler - Laboratoires Dermo Cosmetik Inc. (249335480)

Revised: 1/2019
Document Id: c29ed628-af1e-4be3-8b68-02ce1e1f9a6e
Set id: c6b190d8-d4f4-4775-a51b-46ff91bc641f
Version: 3
Effective Time: 20190108
 
Laboratoires Dermo Cosmetik Inc.