GM COLLIN  MINERAL BB- titanium dioxide and zinc oxide cream 
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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GM Collin®
MINERAL BB

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 8%Sunscreen
Zinc Oxide 3.9%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

  • Stop use and ask a doctor if rash occurs

  • When using this product keep out of eyes. Rinse with water to remove

  • 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 right away

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 liberally 15 minutes before sun exposure, massage until fully absorbed
  • Reapply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours

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, GLYCERIN, CITRULLUS LANATUS (WATERMELON) FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, LENS ESCULENTA (LENTIL) FRUIT EXTRACT, SODIUM LACTATE, SODIUM PCA, IRON OXIDE, LAURYL PEG/PPG-18/18 METHICONE, DECARBOXY CARNOSINE HCL, BUTYLENE GLYCOL, ALBIZIA JULIBRISSIN BARK EXTRACT, SODIUM HYALURONATE, CASSIA ALATA (CANDLE TREE) LEAF EXTRACT, CETEARETH-25, CETYL ALCOHOL, BEHENIC ACID, CHOLESTEROL, CERAMIDE NP, CERAMIDE NS, CERAMIDE EOS, CERAMIDE EOP, CERAMIDE AP, CAPROOYL-PHYTOSPHINGOSINE, CAPROOYL-SPHINGOSINE, TOCOPHERYL ACETATE (VITAMIN E), PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

Questions?

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

PRINCIPAL DISPLAY PANEL - 50 ml Tube Box

PARIS
COLLIN®
G.M.

BEIGE
TINTED

MINERAL BB
CREAM

25 SPF

Broad-Spectrum UVA-UVB
SUNSCREEN

NDC 64127-114-01

All Skin Types

50 ml - Net wt. 1.7 oz.

Principal Display Panel - 50 ml Tube Box
GM COLLIN   MINERAL BB
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64127-114
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
titanium dioxide (titanium dioxide) titanium dioxide8.5 mg  in 100 mL
zinc oxide (zinc oxide) zinc oxide4.2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
ISOHEXADECANE 
TRIETHYLHEXANOIN 
ALUMINUM STEARATE 
ALUMINUM OXIDE 
PEG/PPG-19/19 DIMETHICONE 
WATER 
TRIETHOXYCAPRYLYLSILANE 
ISONONYL ISONONANOATE 
GLYCERIN 
WATERMELON 
APPLE 
LENS CULINARIS FRUIT 
SODIUM LACTATE 
SODIUM PYRROLIDONE CARBOXYLATE 
FERRIC OXIDE RED 
LAURYL PEG/PPG-18/18 METHICONE 
DECARBOXY CARNOSINE HYDROCHLORIDE 
BUTYLENE GLYCOL 
ALBIZIA JULIBRISSIN BARK 
HYALURONATE SODIUM 
CETEARETH-25 
CETYL ALCOHOL 
BEHENIC ACID 
CHOLESTEROL 
N-HEXANOYLSPHINGOSINE 
.ALPHA.-TOCOPHEROL 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64127-114-011 in 1 BOX
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/14/2014
Labeler - Laboratoires dermo Cosmetik Inc (249335480)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires dermo Cosmetik Inc249335480MANUFACTURE(64127-114)

Revised: 2/2014
Document Id: 7e4aee18-6e84-4af1-b7ca-ed2a58cd1b56
Set id: efa4ebdd-f95b-4b57-b333-1a65bf216ed7
Version: 1
Effective Time: 20140212
 
Laboratoires dermo Cosmetik Inc