Natural FX

Manufacturer
Cover FX Skin Care, Inc.
Effective date
2013-02-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:34:39

Label at a glance#

ProductNatural FX
Active ingredientOCTINOXATE, OCTOCRYLENE, OXYBENZONE
Label structure8 sections

Indications and uses

USES: SUNBURN PROTECTANT SPF 15 THERAPEUTIC BENEFITS: BISBOLOL HELPS REDUCE INFLAMMATION. VITAMIN E NOURISHES AND PROTECTS. DERMATOLOGISTS 1ST CHOICE OIL FREE  FRAGRANCE FREE  CONTAINS NON-COMEDOGENIC INGREDIENTS  DERMAFIX TECHNOLOGY PROVIDES ALL DAY WEAR

Dosage and administration

DIRECTIONS: APPLY PRIOR TO SUN EXPOSURE.

Label contents#

Full prescribing information#

Active Ingredients Section

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS: ACTIVE INGREDIENTS: OCTINOXATE 3.4% w/w, OCTOCRYLENE 2.2% w/w, OXYBENZONE 0.9% w/w

Purpose Section

OTC - PURPOSE SECTION

WATER FRESH FOUNDATION LEAVES SKIN REHYDRATED AND RADIANT LOOKING. REVOLUTIONARY DERMAFIX TECHNOLOGY PROVIDES FLEXIBLE COVERAGE AND ALL DAY WEAR. ENRICHED WITH VITAMIN E TO NOURISH AND PROTECT SKIN FROM DAMAGING FREE RADICALS.

Keep Out Of Reach Of Children Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Enter section text here

Uses

INDICATIONS & USAGE SECTION

USES: SUNBURN PROTECTANT SPF 15

THERAPEUTIC BENEFITS: BISBOLOL HELPS REDUCE INFLAMMATION. VITAMIN E NOURISHES AND PROTECTS.

DERMATOLOGISTS 1ST CHOICE OIL FREE  FRAGRANCE FREE  CONTAINS NON-COMEDOGENIC INGREDIENTS  DERMAFIX TECHNOLOGY PROVIDES ALL DAY WEAR

Warning Section

WARNINGS SECTION

WARNINGS:

THE SUN MAY CAUSE SUNBURN, PREMATURE AGING OF THE SKIN AND SKIN CANCER. AVOIDING THE SUN, WEARING PROTECTIVE CLOTHING AND REGULAR USE OF SUNSCREEN OVER THE YEARS MAY REDUCE THE CHANCE OF THESE HARMFUL EFFECTS.

DISCONTINUE USE IF SKIN IRRITATION DEVELOPS OR INCREASES. IF SKIN IRRITATION PERSISTS, CONTACT A HEALTH CARE PRACTITIONER. AVOID CONTACT WITH EYES.

Directions

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS:

APPLY PRIOR TO SUN EXPOSURE.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

WATER, CYCLOMETHICONE, DIIOSTEARYL MALATE,POLYGLYCERYL-2 TRIISOSTEARATE, NEOPENTYL GLYCOL DICAPRATE, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, BIS-PEG/PPG-14/14 DIMETHICONE,TRICONTANYL PVP, SYNTHETIC BEESWAX,CARNAUBA WAX, CETYL PEG/PPG-10/1 DIMETHICONE, MAGNESIUM SILICATE, HYDROGENATED POLYISOBUTENE, CHOLESTERYL HYDROXYSTEARATE,
TOCOPHEROL, BISABOLOL, GLYCERYL BEHENATE, TRIETHOXYCAPRYLYL SILANE, SODIUM CHLORIDE,C24-28 ALKYL METHICONE, MAGNESIUM ALUMINUM SILICATE, SORBIC ACID, PHENOXYETHANOL, DEHYDROACETIC ACID, GLYCERYL DIBEHENATE,
SALICYCLIC ACID, TRIBEHENIN, BENZOIC ACID, BENZYL ALCOHOL, BENZETHONIUM CHLORIDE, BHT

MAY CONTAIN:

TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), CHROMIUM OXIDE GREENS (CI 77288)

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATURAL FX

WATER BASED
FOUNDATION

SPF 15 FPS
DIN 02248412

30Ml/1.0 fl oz

WATER FRESH FOUNDATION LEAVES SKIN REHYDRATED AND RADIENT LOOKING. REVOLUUTIONARY DERMAFIX TECHNOLOGY PROVIDES FLEXIBLE COVERAGE AND ALL DAY WEAR. ENRICHED WITH VITAMIN e TO NOURISH AND PROTECT SKIN FROM DAMAGING FREE RADICALS.

WARNING: CONTAINS BENZOPHENONE-3      PLEASE RECYCLE

COVER FX
DIST. BY/PAR
COVER FX SKIN CARE INC.
TORONTO, ONTARIO
CANADA M3J 2W8. LONDON W1V 2LD
MADE IN/FABRIQUÉ AU CANADA
WWW.COVERFX.COM

DERMATOLOGISTS 1ST CHOICE
∙ OIL FREE ∙ FRAGRANCE FREE ∙ CONTAINS NON-COMEDOGENIC INGREDIENTS
∙ DERMAFIX TECHNOLOGY PROVIDES ALL DAY WEAR
THERAPEUTIC BENEFITS:
BISABOLOL HELPS REDUCE INFLAMMATION. VITAMIN E NOURISHES AND PROTECTS.
SHAKE WELL BEFORE USE.

YOU MAY REPORT A SERIOUS ADVERSE AFFECT FROM USE OF THIS PRODUCT TO (USA) COVER FX 33 ELM STREET, SUITE 377, CHAMPLANE, NY 12919

(CANADA) COVER FX, 1681 FLINT RD, TORONTO, ON M3J 2W8

NATURAL FX1 LABELNATURAL FX1 LABEL

NATURAL FX12LABELNATURAL FX12LABEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68327-002-012020-01-31C16284748780-19d75b9d0-885a-f424-e053-dadaa90a57ce91070828-a997-4fdb-9829-a71186a4f778

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68327-002-01Natural FX30 mL in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68327-002NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1Legacy NDC, 1 package rows20130221_91070828-a997-4fdb-9829-a71186a4f778.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D057441
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)INACTIVE INGREDIENT035JKJ76MT1
CHOLESTERYL HYDROXYSTEARATEINACTIVE INGREDIENTO6K1LG6N4D1
CHROMIC OXIDEINACTIVE INGREDIENTX5Z09SU8591
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6R1
DIISOSTEARYL MALATEINACTIVE INGREDIENTQBS8A3XZGQ1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS21
HYDROGENATED POLYBUTENE (370 MW)INACTIVE INGREDIENTV5H81038781
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N91
NEOPENTYL GLYCOL DICAPRATEINACTIVE INGREDIENT77T908SE821
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
TRIACONTANYL PVP (WP-660)INACTIVE INGREDIENTN0SS3Q238D1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ01
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68327-00268327-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 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 7 · 396 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PARENTERAL584 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERYL DIBEHENATEGLYCERYL DIBEHENATER8WTH25YS2TABLET / ORAL120 mgExact identifier — unii candidate
13 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / VAGINAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVESICAL351 mgExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZCREAM, AUGMENTED / TOPICAL7.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, DELAYED RELEASE / ORAL230 mgExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERYL DIBEHENATEGLYCERYL DIBEHENATER8WTH25YS2POWDER, FOR SOLUTION / ORAL8 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / OPHTHALMIC0.08 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / VAGINAL0.05 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR45 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSYRUP / ORAL20 mgExact identifier — unii candidate
23 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRATHECAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRABURSAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBARACHNOID0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, EXTENDED RELEASE / ORAL0.03 mgExact identifier — unii candidate
32 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERYL DIBEHENATEGLYCERYL DIBEHENATER8WTH25YS2TABLET, FILM COATED, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
13 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCONCENTRATE / ORAL410 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / NASAL7.4 mg/1mlExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCGRANULE, FOR SUSPENSION / ORAL12.5 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSUSPENSION / ORAL40 mgExact identifier — unii candidate
19 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744SOLUTION/ DROPS / AURICULAR (OTIC)0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAMUSCULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9WAFER / ORAL22 mgExact identifier — unii candidate
10 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL, METERED / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET / ORAL231 mgExact identifier — unii candidate
134 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2922 mgExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
17 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
45f8e99c-9a20-44ad-bf4b-1cd53d0fb2e591070828-a997-4fdb-9829-a71186a4f7782013-02-20WarningsExact identifier
spl id: 45f8e99c-9a20-44ad-bf4b-1cd53d0fb2e5
spl set id: 91070828-a997-4fdb-9829-a71186a4f778

Reported adverse events (FAERS/openFDA)#

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