Label: MINT GLAZE FX- octinoxate, oxybenzone ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 68327-004-01 - Packager: Cover FX Skin Care, 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 19, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient Section
- Purpose Section
- Keep Out of Reach of Children Section
- Uses Section
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Warnings Section
THE SUN MAY CAUSE SUNBURN, PREMATURE AGING OF THE SKIN AND SKIN CANCER. AVOIDING THE SUN, WEARING PROTECTIVE CLOTHING AND THE REGULAR USE OF SUNSCREENS OVER THE YEARS MAY REDUCE THE CHANCE OF THESE HARMFUL EFFECTS. DISCONTINUE USE IF SKIN IRRITATION DEVELOPS OR INCREASES. IF IRRITATION PERSISTS, CONSULT A HEALTH CARE PRACTITIONER. FOR EXTERNAL USE ONLY.
- Directions Section
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Inactive Ingredient Section
INACTIVE INGREDIENTS: HYDROGENATED POLYISOBUTENE, POLYGLCERYL-2 TRIISOSTEARATE, TRIDECYL TRIMELLITATE, CYCLOPENTASILOXANE, POLYETHYLENE, C10-30 CHOLESTEROL/LANOSTEROL ESTERS, BUTYROSPERMUM PARKII (SHEA BUTTER), DIPALMITOYL HYDROXYPROLINE, MENTHA PIPERITA (PEPPERMINT), ETHYLHEXYL PALMITATE, TOCOPHERYL ACETATE, CHOLESTERYL HYDROXYSTEARATE, TETRAHEXYLDECYL ASCORBATE, LINOLEIC ACID, LINOLENIC ACID, TRIBEHENIN, SORBITAN ISOSTERATE, SILICA DIMETHYL SILYLATE, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, PHENOXYETHANOL, HEXYLENE GLYCOL, SODIUM HYALURONATE, PALMITOYL OLIGOPEPTIDE, SILICA, TIN OXIDE
MAY CONTAIN: MICA (CI 77499), TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), CARMINE (CI 75470), RED 6 LAKE (CI 15850), RED 7 LAKE (CI 15850), RED 27 LAKE (CI 45410), YELLOW 5 LAKE (CI 19140)
- Package Label Section
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INGREDIENTS AND APPEARANCE
MINT GLAZE FX
octinoxate, oxybenzone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68327-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) MENTHA PIPERITA (UNII: 79M2M2UDA9) ETHYLHEXYL PALMITATE (UNII: 2865993309) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHOLESTERYL HYDROXYSTEARATE (UNII: O6K1LG6N4D) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) LINOLEIC ACID (UNII: 9KJL21T0QJ) LINOLENIC ACID (UNII: 0RBV727H71) TRIBEHENIN (UNII: 8OC9U7TQZ0) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STANNIC OXIDE (UNII: KM7N50LOS6) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) COCHINEAL (UNII: TZ8Z31B35M) D&C RED NO. 6 (UNII: 481744AI4O) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68327-004-01 3 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/09/2010 Labeler - Cover FX Skin Care, Inc. (202908021) Registrant - Cover FX Skin Care, Inc. (202908021)
