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GMC Medical

Laboratoires Dermo Cosmetik Inc

GMC Medical Sun Protection Cream


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

Zinc oxide 10.5%
Octinoxate 7.5%

Purpose

Sunscreen

GMC Medical 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

GMC Medical 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.

GMC Medical

GMC Medical

zinc oxide and octinoxate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64127-134
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Zinc Oxide Zinc oxide 11.6 mg
OCTINOXATE OCTINOXATE 8.3 mg

Inactive Ingredients

Ingredient Name Strength
water
cyclomethicone
DIMETHICONE
PHENYL TRIMETHICONE
HIGH DENSITY POLYETHYLENE
ISODODECANE
HECTORITE
PROPYLENE CARBONATE
PPG-3 MYRISTYL ETHER
MICA
SILICON DIOXIDE
POLYGLYCERYL-10 DECAOLEATE
GLYCERIN
POLYGONUM AVICULARE TOP
SENNA ALATA LEAF
PANTHENOL
.ALPHA.-TOCOPHEROL ACETATE
ACACIA
XANTHAN GUM
TRIETHOXYCAPRYLYLSILANE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 TUBE
2 NDC:64127-134-03 3 in 1 TUBE
3 120 in 1 BOTTLE
4 NDC:64127-134-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-02-10


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