GMC Medical® Sun Protection Cream

Drug Labeling and Warnings

Drug Details [pdf]

GMC MEDICAL  SUN PROTECTION- zinc oxide and octinoxate 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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GMC Medical®
Sun Protection Cream

Drug Facts

Active ingredients

Zinc oxide 10.5%
Octinoxate 7.5%

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 generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours, or after swimming, towel drying, heavy perspiration or showering.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Ask a doctor before using on infants under 6 months.

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.

Inactive ingredients

WATER/EAU, CYCLOMETHICONE, DIMETHICONE, PHENYL TRIMETHICONE, POLYETHYLENE, ISODODECANE, DISTEARDIMONIUM, HECTORITE, PROPYLENE CARBONATE, PPG-3 MYRISTYL ETHER, PPG-3 MYRISTYL ETHER NEOHEPTANOATE, CETYL PEG/PPG-10/1 DIMETHICONE, MICA, SILICA, POLYGLYCERYL-10 DECAOLEATE, GLYCERIN, POLYGONUM AVICULARE EXTRACT, CETYL DIMETHICONE, CASSIA ALATA (CANDLE TREE) LEAF EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, ACACIA SENEGAL GUM, XANTHAN GUM, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

Other information

Store at 59-86°F (15-30°C).

Questions?

USA: 1 (800) 341-1531

CANADA: 1 (800) 361-1263

PRINCIPAL DISPLAY PANEL - 50 ml Tube Box

GMC MEDICAL®

SUN PROTECTION CREAM
BROAD-SPECTRUM UVA-UVB

SPF
45

All Skin Types
Paraben-Free ■ Fragrance-Free

NDC: 64127-134-01

50 ml – Net wt. 1.9 oz.

Principal Display Panel - 50 ml Tube Box
GMC MEDICAL   SUN PROTECTION
zinc oxide and octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64127-134
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide11.6 mg  in 100 mL
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate8.3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ISODODECANE (UNII: A8289P68Y2)  
HECTORITE (UNII: 08X4KI73EZ)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ACACIA (UNII: 5C5403N26O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64127-134-011 in 1 BOX02/10/201409/04/2015
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 64127-134-033 mL in 1 TUBE; Type 0: Not a Combination Product02/10/201409/04/2015
3NDC: 64127-134-021 in 1 BOX02/10/201409/04/2015
3120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/10/201409/04/2015
Labeler - Laboratoires dermo Cosmetik Inc (249335480)

Revised: 1/2019
Document Id: 835f7ea0-eb52-4fc1-a9d1-ad858eade186
Set id: ac266b2b-a185-41f1-8fc1-1345d2acea82
Version: 2
Effective Time: 20190122