FDA.reportPublic FDA data

GMC Medical

Manufacturer
Laboratoires dermo Cosmetik Inc
Effective date
2014-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:20

Label at a glance#

ProductGMC Medical
Active ingredientzinc oxide, octinoxate
Label structure10 sections

Indications and 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.

Dosage and administration

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 sun...

Storage and handling

Store at 59-86°F (15-30°C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 10.5%
Octinoxate 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product:

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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.

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

Store at 59-86°F (15-30°C).

QUESTIONS?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64127-174-012019-11-27C16284748780-19855e2a2-3dec-60a7-e053-dbdaa90a05bdGMC Medical ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64127-134-01GMC Medical50 mL in 1 TUBECREAM50 mL8.3 mg in 100mL1
64127-174-01GMC Medical1 in 1 BOXKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64127-134GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]1Legacy NDC20140210_104e5e32-7b73-41e6-b40a-41fe5556c036.zip
64127-174GMC MEDICAL (ZINC OXIDE AND OCTINOXATE) KIT [LABORATOIRES DERMO COSMETIK INC]1Legacy NDC, 2 package rows20140210_104e5e32-7b73-41e6-b40a-41fe5556c036.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
octinoxateACTIVE INGREDIENT4Y5P7MUD511
zinc oxideACTIVE INGREDIENTSOI2LOH54Z1
octinoxateACTIVE MOIETY4Y5P7MUD511
zinc oxideACTIVE MOIETYSOI2LOH54Z1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HECTORITEINACTIVE INGREDIENT08X4KI73EZ1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
ISODODECANEINACTIVE INGREDIENTA8289P68Y21
MICAINACTIVE INGREDIENTV8A1AW08801
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R1
POLYGLYCERYL-10 DECAOLEATEINACTIVE INGREDIENTNJR3XZA3NW1
POLYGONUM AVICULARE TOPINACTIVE INGREDIENTZCD6009IUF1
PPG-3 MYRISTYL ETHERINACTIVE INGREDIENT7913J43WZ51
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51E1
SENNA ALATA LEAFINACTIVE INGREDIENT4BXR6YZN921
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 3 · 115 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64127-13464127-134-01
64127-17464127-174-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 4 · 155 matching rows.

Name, UNII, Kind table
NameUNIIKind
zinc oxideSOI2LOH54ZACTIB
octinoxate4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
DIMETHICONE92RU3N3Y1OIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
PPG-3 MYRISTYL ETHER7913J43WZ5IACT
MICAV8A1AW0880IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYGLYCERYL-10 DECAOLEATENJR3XZA3NWIACT
GLYCERINPDC6A3C0OXIACT
ISODODECANEA8289P68Y2IACT
HECTORITE08X4KI73EZIACT
PROPYLENE CARBONATE8D08K3S51EIACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
SENNA ALATA LEAF4BXR6YZN92IACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RINGR
OCTYLDODECANOL461N1O614YINGR
CETEARYL ISONONANOATEP5O01U99NIINGR
C14-22 ALCOHOLSB1K89384RJINGR
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAINGR
HEXYLENE GLYCOLKEH0A3F75JINGR
PPG-5-CETETH-204AAN25P8P4INGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
ARACHIDYL PROPIONATEQV5DAH3MSBINGR
.ALPHA.-TOCOPHEROLH4N855PNZ1INGR
VITAMIN A PALMITATE1D1K0N0VVCINGR
ETHYL LINOLEATEMJ2YTT4J8MINGR
ETHYL LINOLENATET54Y8H042VINGR
BUTYLENE GLYCOL3XUS85K0RAINGR
PENTYLENE GLYCOL50C1307PZGINGR
HYDROXYPHENYL PROPAMIDOBENZOIC ACID25KRT26H77INGR
POTASSIUM HYDROXIDEWZH3C48M4TINGR
CETYL ALCOHOL936JST6JCNINGR

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 157 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / DENTAL60 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SUPPOSITORY / RECTALNAExact identifier — unii candidate
18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CAPSULE / ORAL10 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
PROPYLENE CARBONATEPROPYLENE CARBONATE8D08K3S51EOINTMENT / TOPICAL3000 mgExact identifier — unii candidate
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SUPPOSITORY / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CREAM / TOPICAL54.5 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
18 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CAPSULE, EXTENDED RELEASE / ORAL4.53 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c9a20ee6-78f8-4a61-9b48-95f37ddcf8dd104e5e32-7b73-41e6-b40a-41fe5556c0362014-02-03WarningsExact identifier
spl id: c9a20ee6-78f8-4a61-9b48-95f37ddcf8dd
spl set id: 104e5e32-7b73-41e6-b40a-41fe5556c036

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.