Indications and uses
SUNSCREEN
SUNSCREEN
APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. SUN PROTECTION MEASURES; SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER PROTECTION MEASURES INCLUDING: LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES
DRUG FACTS
ACTIVE INGREDIENTS:
OCTOCRYLENE 8.5% W/W, OCTISALATE 5.0% W/W, AVOBENZONE 3.0% W/W
SUNSCREEN
KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
HELPS PREVENT, OR PROTECTS FROM SUNBURN. SUNBURN PROTECTANT SPF 30 IF USED AS DIRECTED WITH OTHER SUN PROTECTION METHODS (SEE DIRECTIONS). DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.
WARNINGS: FOR EXTERNAL USE ONLY. DO NOT USE ON DAMAGED OR BROKEN SKIN. STOP USE AND ASK A DOCTOR IF RASH OCCURS. WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. THE SUN MAY CAUSE SUNBURN, PREMATURE AGING OF THE SKIN AND SKIN CANCER. AVOIDING THE SUN, WEARING PROTECTIVE CLOTHING AND 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. AVOID CONTACT WITH EYES.
YOU MAY REPORT A SERIOUS ADVERSE EFFECT FROM USE OF THIS PRODUCT TO (USA) COVER FX 33 ELM STREET SUITE 377, CHAMPLAIN, NY 12919 (CAN) COVER FX, 1681 FLINT ROAD, TORONTO, M3J 2W8
APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
SUN PROTECTION MEASURES; SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER PROTECTION MEASURES INCLUDING:
ANTIOXIDANT INFUSED FULL COVERAGE FOUNDATION AND CONCEALER IN ONE WITH BROAD SPECTRUM SPF 30 PROTECTION. GIVES AN ALL-DAY SATIN FINISH THAT NOURISHES AND PROTECTS WITH ANTI-AGING BENEFITS. CLINICALLY TESTED. PARABEN, FRAGRANCE, GLUTEN, MINERAL OIL AND TALC FREE.
OTHER INFORMATION: PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
BISABOLOL, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CERAMIDE 2, CHROMIUM OXIDE BREENS (CL 77288), COPERNICIA CERIFERA (CARNAUBA) WAX, DEHYDROACETIC ACID, DIISOSTEARYL MALATE, ETHYL LINOLEATE, ETHYL LINOLENATE, ETHYL OLEATE, HYDROGENATEDD POLYISOBUTENE, IRON OXIDES (CL 77491, CL 77499, CL 77499), NEOPENTYL GLYCOL DICAPRATE, PALMITOYL OLIGOPEPTIDE, PEG-10 RAPESEED STEROL, PHYTOSPHINGOSINE, POLYGLYCERL-2 TRIISOSSTEARATE, SILICA, SQUALANE, SYNTHETIC BEESWAX, TETRAHEXYLDECYL ASCORBATE, TOCOPHEROL, TRICONTANYL PVP, TRIBEHENIN, TRIETHOXYCAPRYLYLSILANE, TRIS (PPG-3 BENTZYL ETHER) CITRATE, TITANIUM DIOXIDE (CL 77891)
COVER l FX
TOTAL COVER CREAM FOUNDATION
BROAD SPECTRUM
SPF 30
NET WT/ 10G/0.35 OZ e
CRUELTY FREE
DIST. BY COVER FX SKIN CARE INC.
TORONTO, ONTARIO CANADA M3J 2W8. LONDON W1V 2LD
MADE IN CANADA
WWW.COVERFX.COM
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68327-010-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2afa-f424-e053-dadaa90a57ce | cd287df1-393a-477a-b23c-39ae08ac294a |
| 68327-010-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2afa-f424-e053-dadaa90a57ce | cd287df1-393a-477a-b23c-39ae08ac294a |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68327-010-01 | COVER FX TOTAL COVER FOUNDATIONSPF 30 | 10 g in 1 CASE | CREAM | 10 | 5 | |
| 68327-010-03 | COVER FX TOTAL COVER FOUNDATIONSPF 30 | 1.5 g in 1 PACKET | CREAM | 1.5 | 5 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 5 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 5 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 5 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 5 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 5 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 5 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 5 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 5 | |
| CERAMIDE 2 | INACTIVE INGREDIENT | C04977SRJ5 | 5 | |
| CHROMIC OXIDE | INACTIVE INGREDIENT | X5Z09SU859 | 5 | |
| DEHYDROACETIC ACID | INACTIVE INGREDIENT | 2KAG279R6R | 5 | |
| DIISOSTEARYL MALATE | INACTIVE INGREDIENT | QBS8A3XZGQ | 5 | |
| ETHYL LINOLEATE | INACTIVE INGREDIENT | MJ2YTT4J8M | 5 | |
| ETHYL LINOLENATE | INACTIVE INGREDIENT | T54Y8H042V | 5 | |
| ETHYL OLEATE | INACTIVE INGREDIENT | Z2Z439864Y | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 5 | |
| HYDROGENATED POLYBUTENE (370 MW) | INACTIVE INGREDIENT | V5H8103878 | 5 | |
| LEVOMENOL | INACTIVE INGREDIENT | 24WE03BX2T | 5 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 5 | |
| NEOPENTYL GLYCOL DICAPRATE | INACTIVE INGREDIENT | 77T908SE82 | 5 | |
| PALMITOYL OLIGOPEPTIDE | INACTIVE INGREDIENT | HO4ZT5S86C | 5 | |
| PEG-10 RAPESEED STEROL | INACTIVE INGREDIENT | 258O76T85M | 5 | |
| PHYTOSPHINGOSINE | INACTIVE INGREDIENT | GIN46U9Q2Q | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 5 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 5 | |
| TETRAHEXYLDECYL ASCORBATE | INACTIVE INGREDIENT | 9LBV3F07AZ | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 5 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 5 | |
| TRIBEHENIN | INACTIVE INGREDIENT | 8OC9U7TQZ0 | 5 | |
| TRICONTANYL POVIDONE (4 TRICONTANYL BRANCHES/REPEAT) | INACTIVE INGREDIENT | N0SS3Q238D | 5 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68327-010 | 68327-010-01, 68327-010-03 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | SUSPENSION / ORAL | 6 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| DEHYDROACETIC ACID | DEHYDROACETIC ACID | 2KAG279R6R | LOTION / TOPICAL | 1 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | LOTION / TOPICAL | 7 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, SUGAR COATED / ORAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | LOTION / TOPICAL | NA | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | INJECTION, EMULSION / INTRAVENOUS | 1.1 %w/v | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, CHEWABLE / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | GUM, CHEWING / BUCCAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 990.3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / BUCCAL | 1 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | AEROSOL, FOAM / TOPICAL | 2.23 %w/w | ||
| SQUALANE | SQUALANE | GW89575KF9 | SOLUTION / TOPICAL | 1 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, COATED / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | GEL / TOPICAL | 12 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / SUBLINGUAL | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET / ORAL | 2 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | CREAM, AUGMENTED / TOPICAL | 120 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg |
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 |
|---|---|---|---|---|---|---|
| 20b2c5ff-19eb-4427-9d33-38c18054d639 | cd287df1-393a-477a-b23c-39ae08ac294a | 2013-10-28 | Warnings | 20b2c5ff-19eb-4427-9d33-38c18054d639 cd287df1-393a-477a-b23c-39ae08ac294a |
Adverse event summaries are temporarily unavailable. Other product information remains available.