Label: GMC MEDICAL- zinc oxide and octinoxate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 64127-134-01, 64127-174-01 - Packager: Laboratoires dermo Cosmetik Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 3, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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
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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.
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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
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
GMC MEDICAL
zinc oxide and octinoxate kitProduct 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 creamProduct 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) lotionProduct 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 creamProduct 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 gelProduct 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)
