MINT GLAZE FX- octinoxate, oxybenzone ointment

Mint Glaze FX by

Drug Labeling and Warnings

Mint Glaze FX by is a Otc medication manufactured, distributed, or labeled by Cover FX Skin Care, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient Section

ACTIVE INGREDIENTS; OCTINOXATE 7.5% w/w  OXYBENZONE 2.5% w/w

Purpose Section

MOISTURIZING LIP TREAT-MINT PRIMER  SPF 15

THIS PROTECTIVE FORTIFYING AND FRESHENING GLAZED BALM MAINTAINS YOUTHFUL LOOKING LIPS.

USE AS A POUT PERFECTING PRIMER TO SOFTEN THE APPEARANCE OF LINES AND HYDRATE LIPS.

Keep Out of Reach of Children Section

KEEP OUT OF REACH OF CHILDREN

Uses Section

USES: SUNBURN PROTECTANT SPF 15

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

DIRECTIONS  APPLY PRIOR TO SUN EXPOSURE. REAPPLY AS NEEDED OR AFTER EATING AND DRINKING.

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

MINT GLAZE FX

3 ml/0.10 FL OZ LIQUID  CRUELTY FREE NO ANIMAL TESTING  30 PERCENT RECYCLE  PLEASE RECYCLE

COVER FX DIST. BY COVER FX SKIN CARE INC. TORONTO, ONTARIO CANADA M3J 2W8.  WWW.COVERFX.COM

INGREDIENTS AND APPEARANCE

MINT GLAZE FX 
octinoxate, oxybenzone ointment

Product 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)