GMC MEDICAL- zinc oxide and octinoxate kit

GMC Medical by

Drug Labeling and Warnings

GMC Medical by is a Otc medication manufactured, distributed, or labeled by Laboratoires dermo Cosmetik Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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, 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

INGREDIENTS AND APPEARANCE

GMC MEDICAL 
zinc oxide and octinoxate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64127-174

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64127-174-01	1 in 1 BOX

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	50 mL
Part 2	1 BOTTLE, PUMP	200 mL
Part 3	1 BOTTLE, PUMP	50 mL
Part 4	1 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	11.6 mg  in 100 mL
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	8.3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64127-134-01	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/10/2014

Part 2 of 4

GMC MEDICAL   SOOTHING CLEANSING MILK
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	OCTYLDODECANOL (UNII: 461N1O614Y)
INGR	CETEARYL ISONONANOATE (UNII: P5O01U99NI)
INGR	C14-22 ALCOHOLS (UNII: B1K89384RJ)
INGR	C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
INGR	.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
INGR	ETHYL LINOLENATE (UNII: T54Y8H042V)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
INGR	POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	DEHYDROACETIC ACID (UNII: 2KAG279R6R)
INGR	BENZYL ALCOHOL (UNII: LKG8494WBH)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		200 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		02/10/2014

Part 3 of 4

GMC MEDICAL  GF ADVANCED DERM
other skin care preparations cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-75 STEARATE (UNII: OT38R0N74H)
INGR	CETETH-20 (UNII: I835H2IHHX)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	CETEARYL ISONONANOATE (UNII: P5O01U99NI)
INGR	PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	WATERMELON (UNII: 231473QB6R)
INGR	APPLE (UNII: B423VGH5S9)
INGR	LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
INGR	ANHYDROXYLITOL (UNII: 8XWR7NN42F)
INGR	XYLITOL (UNII: VCQ006KQ1E)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
INGR	NEPIDERMIN (UNII: TZK30RF92W)
INGR	CETEARETH-25 (UNII: 8FA93U5T67)
INGR	BEHENIC ACID (UNII: H390488X0A)
INGR	CHOLESTEROL (UNII: 97C5T2UQ7J)
INGR	N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)
INGR	PARAFFIN (UNII: I9O0E3H2ZE)
INGR	PADINA PAVONICA (UNII: 177U06NHZI)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	TRIBEHENIN (UNII: 8OC9U7TQZ0)
INGR	CERAMIDE 2 (UNII: C04977SRJ5)
INGR	PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
INGR	PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
INGR	HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
INGR	BARLEY (UNII: 5PWM7YLI7R)
INGR	CUCUMBER (UNII: YY7C30VXJT)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
INGR	.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
INGR	CYCLOMETHICONE 4 (UNII: CZ227117JE)
INGR	ISOPROPYLBENZYL SALICYLATE (UNII: 0798EIC152)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	TEPRENONE (UNII: S8S8451A4O)
INGR	DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)
INGR	ERGOTHIONEINE (UNII: BDZ3DQM98W)
INGR	MADECASSOSIDE (UNII: CQ2F5O6YIY)
INGR	OCTYLDODECANOL (UNII: 461N1O614Y)
INGR	ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	CERAMIDE 3 (UNII: 4370DF050B)
INGR	LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
INGR	CHLORPHENESIN (UNII: I670DAL4SZ)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		50 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		02/10/2014

Part 4 of 4

GMC MEDICAL   GF ADVANCED DERM SERUM
other skin care preparations gel

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	PREZATIDE (UNII: 39TG2H631E)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	DEXTROSE (UNII: IY9XDZ35W2)
INGR	CARRAGEENAN (UNII: 5C69YCD2YJ)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	CYCLOMETHICONE 6 (UNII: XHK3U310BA)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CETEARETH-25 (UNII: 8FA93U5T67)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	BEHENIC ACID (UNII: H390488X0A)
INGR	CHOLESTEROL (UNII: 97C5T2UQ7J)
INGR	N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)
INGR	LAURETH-3 (UNII: F32E4CB0UJ)
INGR	ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)
INGR	WATERMELON (UNII: 231473QB6R)
INGR	APPLE (UNII: B423VGH5S9)
INGR	LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	NEPIDERMIN (UNII: TZK30RF92W)
INGR	BASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V)
INGR	MECASERMIN (UNII: 7GR9I2683O)
INGR	CYCLOMETHICONE 4 (UNII: CZ227117JE)
INGR	C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
INGR	LAURETH-7 (UNII: Z95S6G8201)
INGR	SORBIC ACID (UNII: X045WJ989B)
INGR	ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
INGR	DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
INGR	WHEY (UNII: 8617Z5FMF6)
INGR	MADECASSOSIDE (UNII: CQ2F5O6YIY)
INGR	ERGOTHIONEINE (UNII: BDZ3DQM98W)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)
INGR	XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
INGR	ANHYDROXYLITOL (UNII: 8XWR7NN42F)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		02/10/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/10/2014

Labeler - Laboratoires dermo Cosmetik Inc (249335480)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires dermo Cosmetik Inc		249335480	MANUFACTURE(64127-134, 64127-174)