GMC MEDICAL- zinc oxide and octinoxate 
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®

Drug Facts

Active ingredients

Zinc oxide 10.5%
Octinoxate 7.5%

Purpose

Sunscreen

Uses

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

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, 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
GMC MEDICAL 
zinc oxide and octinoxate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64127-174
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64127-174-011 in 1 BOX
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 50 mL
Part 21 BOTTLE, PUMP 200 mL
Part 31 BOTTLE, PUMP 50 mL
Part 41 BOTTLE, PUMP 30 mL
Part 1 of 4
GMC MEDICAL   SUN PROTECTION
zinc oxide and octinoxate cream
Product Information
Item 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)  
PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISODODECANE (UNII: A8289P68Y2)  
HECTORITE (UNII: 08X4KI73EZ)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64127-134-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/10/2014
Part 2 of 4
GMC MEDICAL   SOOTHING CLEANSING MILK
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGROCTYLDODECANOL (UNII: 461N1O614Y)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRC14-22 ALCOHOLS (UNII: B1K89384RJ)  
INGRC12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGRPPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
INGR.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
INGRETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
INGRETHYL LINOLENATE (UNII: T54Y8H042V)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRHYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
INGRPOTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRDEHYDROACETIC ACID (UNII: 2KAG279R6R)  
INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1200 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic02/10/2014
Part 3 of 4
GMC MEDICAL  GF ADVANCED DERM
other skin care preparations cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRPEG-75 STEARATE (UNII: OT38R0N74H)  
INGRCETETH-20 (UNII: I835H2IHHX)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRPALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
INGRSQUALANE (UNII: GW89575KF9)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRPPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRWATERMELON (UNII: 231473QB6R)  
INGRAPPLE (UNII: B423VGH5S9)  
INGRLENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRXYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
INGRANHYDROXYLITOL (UNII: 8XWR7NN42F)  
INGRXYLITOL (UNII: VCQ006KQ1E)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRDICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
INGRNEPIDERMIN (UNII: TZK30RF92W)  
INGRCETEARETH-25 (UNII: 8FA93U5T67)  
INGRBEHENIC ACID (UNII: H390488X0A)  
INGRCHOLESTEROL (UNII: 97C5T2UQ7J)  
INGRN-HEXANOYLSPHINGOSINE (UNII: 038753E78J)  
INGRPARAFFIN (UNII: I9O0E3H2ZE)  
INGRPADINA PAVONICA (UNII: 177U06NHZI)  
INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGRTRIBEHENIN (UNII: 8OC9U7TQZ0)  
INGRCERAMIDE 2 (UNII: C04977SRJ5)  
INGRPEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
INGRPROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
INGRHELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
INGRBARLEY (UNII: 5PWM7YLI7R)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRDIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
INGR.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
INGRCYCLOMETHICONE 4 (UNII: CZ227117JE)  
INGRISOPROPYLBENZYL SALICYLATE (UNII: 0798EIC152)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRTEPRENONE (UNII: S8S8451A4O)  
INGRDECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)  
INGRERGOTHIONEINE (UNII: BDZ3DQM98W)  
INGRMADECASSOSIDE (UNII: CQ2F5O6YIY)  
INGROCTYLDODECANOL (UNII: 461N1O614Y)  
INGRARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
INGRETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRCERAMIDE 3 (UNII: 4370DF050B)  
INGRLYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
150 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic02/10/2014
Part 4 of 4
GMC MEDICAL   GF ADVANCED DERM SERUM
other skin care preparations gel
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRPREZATIDE (UNII: 39TG2H631E)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRTROLAMINE (UNII: 9O3K93S3TK)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRDEXTROSE (UNII: IY9XDZ35W2)  
INGRCARRAGEENAN (UNII: 5C69YCD2YJ)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCETEARETH-25 (UNII: 8FA93U5T67)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRBEHENIC ACID (UNII: H390488X0A)  
INGRCHOLESTEROL (UNII: 97C5T2UQ7J)  
INGRN-HEXANOYLSPHINGOSINE (UNII: 038753E78J)  
INGRLAURETH-3 (UNII: F32E4CB0UJ)  
INGRACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)  
INGRWATERMELON (UNII: 231473QB6R)  
INGRAPPLE (UNII: B423VGH5S9)  
INGRLENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRNEPIDERMIN (UNII: TZK30RF92W)  
INGRBASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V)  
INGRMECASERMIN (UNII: 7GR9I2683O)  
INGRCYCLOMETHICONE 4 (UNII: CZ227117JE)  
INGRC13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
INGRLAURETH-7 (UNII: Z95S6G8201)  
INGRSORBIC ACID (UNII: X045WJ989B)  
INGRARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
INGRDIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
INGRWHEY (UNII: 8617Z5FMF6)  
INGRMADECASSOSIDE (UNII: CQ2F5O6YIY)  
INGRERGOTHIONEINE (UNII: BDZ3DQM98W)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRDECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)  
INGRXYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
INGRANHYDROXYLITOL (UNII: 8XWR7NN42F)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic02/10/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/10/2014
Labeler - Laboratoires dermo Cosmetik Inc (249335480)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires dermo Cosmetik Inc249335480MANUFACTURE(64127-134, 64127-174)

Revised: 2/2014
Document Id: c9a20ee6-78f8-4a61-9b48-95f37ddcf8dd
Set id: 104e5e32-7b73-41e6-b40a-41fe5556c036
Version: 1
Effective Time: 20140203
 
Laboratoires dermo Cosmetik Inc