Active Ingredients
DRUG FACTS
ACTIVE INGREDIENTS:
OCTOCRYLENE 8.5% W/W, OCTISALATE 5.0% W/W, AVOBENZONE 3.0% W/W
Cover Fx Total Cover Foundation
FDA Label NDC 68327-010
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 Cover Fx Total Cover Foundation (NDC 68327-010). 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 ingredients, purpose/uses, keep out of reach of children, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose/Uses
SUNSCREEN
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Uses
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
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
Directions
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
Other Information
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.
Inactive Ingredients
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)
Product Label
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
Cover Fx Totalcoverfoundation Label (Coverfx Totalcoverfoundation)
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