Boxed warning
YOUR MAY REPORT A SERIOUS ADVERSE AFFECT FROM THE USE OF THIS PRODUCT TO: (USA) COVER FX, 33 ELM STREET, SUITE 377, CHAMPLAIN, NY 12919
Skin Tint 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 22:34:38
Label at a glance#
ProductSkin Tint FX
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections
Dosage and administration
DIRECTIONS: APPLY PRIOR TO SUN EXPOSURE. SHAKE WELL BEFORE USAGE
Contacts and useful links#
Websitewww.sfprogram.org
www.sfprogram.org
www.sfprogram.orgWebsitewww.coverfx.com
WWW.COVERFX.COM
WWW.COVERFX.COMLabel contents#
Full prescribing information#
Active Ingredients
DRUG FACTS
ACTIVE INGREDIENTS:
OCTINOXATE 6.50% w/w, OCTISALATE 3.50% w/w, OXYBENZONE 2.10% w/w, TITANIUM DIOXIDE 5.50% w/w, ZINC OXIDE 5.50% w/w
Purpose
USES: SUNBURN PROTECTANT SPF 30
Use
SUNBURN PROTECTANT SPF 30
NATURAL PEARLIZED MINERALS PROVIDE A HINT OF COLOUR TO ENHANCE THE APPEARANCE OF SUN KISSED RADIANCE AND TONE.
INFUSION OF PEPTIDES, CERAMIDES, AND F.A.C.E MULTI-VITAMINS HELPS REJUVENATE, NOURISH, HYDRATE AND PROTECT SKIN. HYALURONIC SPHERES SWELL WITH CAPTURED WATER AND TIME-RELEASED MOISTURE BACK INTO THE SKIN.
Warnings
WARNINGS: THE SUN MAY CAUSE PREMATURE AGING OF THE SKIN AND SKIN CANCER.
AVOID THE SUN, WEARING PROTECTIVE CLOTHING AND REGULAR USE OF SUNSCREENS OVER THE YEARS MAY REDUCE THE CHANCE OF THESE HARMFUL EFFECTS.
WARNING: CONTAINS BENZOPHENONE-3
CAUTION:
DISCONTINUE USE IF SKIN IRRITATION DEVELOPS OR INCREASES. IF IRRITATION PERSISTS, CONSULT A HEALTH CARE PRACTITIONER. AVOID CONTACT WITH EYES.
You may report
YOUR MAY REPORT A SERIOUS ADVERSE AFFECT FROM THE USE OF THIS PRODUCT TO:
(USA) COVER FX, 33 ELM STREET, SUITE 377, CHAMPLAIN, NY 12919
Directions
DIRECTIONS:
APPLY PRIOR TO SUN EXPOSURE.
SHAKE WELL BEFORE USAGE
Inactive Ingredients
INACTIVE INGREDIENTS:
CYCLOPENTASILOXANE, DIMETHICONE CROSSPOLYMER, ETHYLHEXYL PALMITATE, SQUALANE, TRIDECYL TRIMELLITATE, DIMETHICONE /VINYL DIMETHICONE CROSSPOLYMER, BIS-PEG/PPG-14/14 DIMETHICONE, C 12-15 ALKYL BENZOATE, MICA, CETYL PEG/PPG-10/1 DIMETHICONE, DISTEARDIMONIUM HECTORITE, BISABOLOL, TOCOPHEYL ACETATE, DIMETHICONOL, SILIA, ALUMINA, TRIIBEHENIN, BENZYL ALCOHOL, DIMETHICONE/METHICONE COPOLYMER, PHENOXYETHANOL, GLYCERIN, LINOLEIC ACID, LINOLENIC ACID, TETRAHEXYLDECYL ASCORBATE, PEG/PPG-20/15 DIMETHICONE, SILICA, DIMETHYL SILYLATE, CERAMIDE-2, BENZOIC ACID, PEG-10 RAPESEED STEROL, BUTYLENE GLYCOL, TRIETHOXYCAPYLYSILANE, RETINYL PALMITATE, SORBIC ACID, DEHYDROACETIC ACID, CAPRYLYL GLYCOL, LAVANDULA ANGUSTIFOLIA (LAVENDER), HEXYLENE GLYCOL, SODIUM HYALURONATE, PALM OLIGOPEPTIDE
MAY CONTAIN:
TITANIUM OXIDE (CL 77891), IRON OXIDES (CL 77491), CL 77492, CL 77499), CHROMIUM OXIDE GREENS (CL 77288)
Package Label
SKIN TINT FX
MOISTURIZING TREATMENT AND TINT
SPF 30 FPS DIN 02295156 30Ml/1.0 fl oz
OIL FREE, WAX FREE, FRAGRANCE FREE, AND PARABEN FREE.
CRUELTY FREE
Cover Fx
FACEBOOK.COM/COVERFX SUSTAINABLE FORESTRY INITIATIVE Certified Chain of Custody Promoting Sustainable Forest Management www.sfprogram.org
COVER FX
DIST. BY COVER FX SKIN CARE INC. TORONTO, ONTARIO CANADA M3J 2W8. LONDON W1V 2LD MADE IN FABRIQUE AU CANADA
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68327-003-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b407-f424-e053-dadaa90a57ce | 3bf327e1-becf-4981-bc79-d5403ba532ac |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68327-003-01 | Skin Tint FX | 30 mL in 1 TUBE | CREAM | 30 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| CERAMIDE 2 | INACTIVE INGREDIENT | C04977SRJ5 | 1 | |
| CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) | INACTIVE INGREDIENT | 035JKJ76MT | 1 | |
| CHROMIC OXIDE | INACTIVE INGREDIENT | X5Z09SU859 | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| DEHYDROACETIC ACID | INACTIVE INGREDIENT | 2KAG279R6R | 1 | |
| DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER | INACTIVE INGREDIENT | RSA9I561OK | 1 | |
| DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) | INACTIVE INGREDIENT | 9E4CO0W6C5 | 1 | |
| DIMETHICONOL (41 MPA.S) | INACTIVE INGREDIENT | 343C7U75XW | 1 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HEXYLENE GLYCOL | INACTIVE INGREDIENT | KEH0A3F75J | 1 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| LAVENDER OIL | INACTIVE INGREDIENT | ZBP1YXW0H8 | 1 | |
| LEVOMENOL | INACTIVE INGREDIENT | 24WE03BX2T | 1 | |
| LINOLEIC ACID | INACTIVE INGREDIENT | 9KJL21T0QJ | 1 | |
| LINOLENIC ACID | INACTIVE INGREDIENT | 0RBV727H71 | 1 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| PALMITOYL OLIGOPEPTIDE | INACTIVE INGREDIENT | HO4ZT5S86C | 1 | |
| PEG-10 RAPESEED STEROL | INACTIVE INGREDIENT | 258O76T85M | 1 | |
| PEG/PPG-20/15 DIMETHICONE | INACTIVE INGREDIENT | 06R6X77P9C | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| SILICA DIMETHYL SILYLATE | INACTIVE INGREDIENT | EU2PSP0G0W | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | 1 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 1 | |
| TETRAHEXYLDECYL ASCORBATE | INACTIVE INGREDIENT | 9LBV3F07AZ | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TRIBEHENIN | INACTIVE INGREDIENT | 8OC9U7TQZ0 | 1 | |
| TRIDECYL TRIMELLITATE | INACTIVE INGREDIENT | FY36J270ES | 1 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 1 |
Products#
Every source-derived product name is available through these pages.
- Skin Tint FX
- OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE
- OCTINOXATE
- OCTISALATE
- OXYBENZONE
- TITANIUM DIOXIDE
- ZINC OXIDE
- CYCLOMETHICONE 5
- DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER
- ETHYLHEXYL PALMITATE
- SQUALANE
- TRIDECYL TRIMELLITATE
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- ALKYL (C12-15) BENZOATE
- MICA
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
- LEVOMENOL
- .ALPHA.-TOCOPHEROL ACETATE
- DIMETHICONOL (41 MPA.S)
- SILICON DIOXIDE
- ALUMINUM OXIDE
- TRIBEHENIN
- BENZYL ALCOHOL
- PHENOXYETHANOL
- GLYCERIN
- LINOLEIC ACID
- LINOLENIC ACID
- TETRAHEXYLDECYL ASCORBATE
- PEG/PPG-20/15 DIMETHICONE
- CERAMIDE 2
- BENZOIC ACID
- PEG-10 RAPESEED STEROL
- BUTYLENE GLYCOL
- TRIETHOXYCAPRYLYLSILANE
- VITAMIN A PALMITATE
- SORBIC ACID
- DEHYDROACETIC ACID
- CAPRYLYL GLYCOL
- LAVENDER OIL
- HEXYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68327-003 | 68327-003-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / IRRIGATION | 0.02 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / SUBLINGUAL | 1 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, COATED / ORAL | NA | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION/ DROPS / OPHTHALMIC | 0.2 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | GEL / VAGINAL | 100 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SOFT TISSUE | 23 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / ORAL | 360 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | LOTION / TOPICAL | 4000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, DELAYED RELEASE / ORAL | 0.03 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET / SUBLINGUAL | 0.16 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAVENOUS | 242 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| HYALURONATE SODIUM | HYALURONATE SODIUM | YSE9PPT4TH | INJECTION, SUSPENSION / INTRA-ARTICULAR | 23 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | INJECTION, SOLUTION / INTRAMUSCULAR | 0.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | MOUTHWASH / BUCCAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, CHEWABLE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| DEHYDROACETIC ACID | DEHYDROACETIC ACID | 2KAG279R6R | LOTION / TOPICAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d9d95792-6a64-4b61-9fe7-10ca55c7f0c4 | 3bf327e1-becf-4981-bc79-d5403ba532ac | 2013-02-20 | Boxed warning, Warnings | d9d95792-6a64-4b61-9fe7-10ca55c7f0c4 3bf327e1-becf-4981-bc79-d5403ba532ac |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.