Mint Glaze FX

Manufacturer
Cover FX Skin Care, Inc.
Effective date
2013-02-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:34:38

Label at a glance#

ProductMint Glaze FX
Active ingredientOCTINOXATE, OXYBENZONE
Label structure8 sections

Indications and uses

USES: SUNBURN PROTECTANT SPF 15

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

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

Purpose Section

OTC - 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses Section

INDICATIONS & USAGE 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

DOSAGE & ADMINISTRATION 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Product LabelMint Glaze Product Label

Mint Glaze Carton LabelMint Glaze Carton Label


FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68327-004-012020-01-31C16284748780-19d75b9d0-b404-f424-e053-dadaa90a57ce4df1ea18-59e3-4e1b-b1c5-c7a0fa6a6b7e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68327-004-01Mint Glaze FX3 mL in 1 VIALOINTMENT31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68327-004MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.]1Legacy NDC, 1 package rows20130220_4df1ea18-59e3-4e1b-b1c5-c7a0fa6a6b7e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
C10-30 CHOLESTEROL/LANOSTEROL ESTERSINACTIVE INGREDIENT137SL7IL0Y1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CHOLESTERYL HYDROXYSTEARATEINACTIVE INGREDIENTO6K1LG6N4D1
COCHINEALINACTIVE INGREDIENTTZ8Z31B35M1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6K1
D&C RED NO. 6INACTIVE INGREDIENT481744AI4O1
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X81
DIPALMITOYL HYDROXYPROLINEINACTIVE INGREDIENTE6AHA53N1H1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933091
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
HYDROGENATED POLYBUTENE (1300 MW)INACTIVE INGREDIENT7D1YQ9Y5EZ1
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJ1
LINOLENIC ACIDINACTIVE INGREDIENT0RBV727H711
MENTHA PIPERITAINACTIVE INGREDIENT79M2M2UDA91
MICAINACTIVE INGREDIENTV8A1AW08801
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86C1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
SILICA DIMETHYL SILYLATEINACTIVE INGREDIENTEU2PSP0G0W1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SORBITAN ISOSTEARATEINACTIVE INGREDIENT01S2G2C1E41
STANNIC OXIDEINACTIVE INGREDIENTKM7N50LOS61
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZ1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ01
TRIDECYL TRIMELLITATEINACTIVE INGREDIENTFY36J270ES1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68327-00468327-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 192 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
D&C RED NO. 7D&C RED NO. 7ECW0LZ41X8TABLET / ORAL0.5 mgExact identifier — unii candidate
7 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE / ORAL652 mgExact identifier — unii candidate
22 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / OPHTHALMICNAExact identifier — unii candidate
18 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KPOWDER, FOR SUSPENSION / ORAL1.67 mg/5mlExact identifier — unii candidate
4 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / DENTAL60 mgExact identifier — unii candidate
18 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSUSPENSION / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii candidate
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SUPPOSITORY / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii candidate
18 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / BUCCAL0.11 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED, EXTENDED RELEASE / ORAL3.6 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675SUSPENSION, EXTENDED RELEASE / ORAL2.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSUPPOSITORY / VAGINALNAExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / SUBLINGUAL0.11 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WSUSPENSION / ORAL120 mgExact identifier — unii candidate
7 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii candidate
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
D&C RED NO. 7D&C RED NO. 7ECW0LZ41X8TABLET / SUBLINGUAL0.01 mgExact identifier — unii candidate
7 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
7 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CREAM / TOPICAL54.5 %w/wExact identifier — unii candidate
18 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bc82ac98-ca84-407d-98fc-af300754202e4df1ea18-59e3-4e1b-b1c5-c7a0fa6a6b7e2013-02-19WarningsExact identifier
spl id: bc82ac98-ca84-407d-98fc-af300754202e
spl set id: 4df1ea18-59e3-4e1b-b1c5-c7a0fa6a6b7e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.