Gmc Medical
FDA Label NDC 64127-174

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Dermo Cosmetik Inc for the product Gmc Medical (NDC 64127-174). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For external use only

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.

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.

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product:

  • Avoid contact with eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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.

Inactive Ingredients

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

GMC MEDICAL®

ANTI-AGING TREATMENT
GF ADVANCED DERM

NDC 64127-134-01

NDC 64127-174-01

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)

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