Active Ingredient Section
ACTIVE INGREDIENTS; OCTINOXATE 7.5% w/w OXYBENZONE 2.5% w/w
Mint Glaze Fx
FDA Label NDC 68327-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cover Fx Skin Care, Inc. for the product Mint Glaze Fx (NDC 68327-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient section, purpose section, keep out of reach of children section, uses section, warnings section, directions section, inactive ingredient section, package label section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Mint Glaze Carton Label (Cover Fx Mint Glaze2)
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