Skin Tint Fx
FDA Label NDC 68327-003

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 Skin Tint Fx (NDC 68327-003). 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, keep out of reach of children, use, warnings, you may report, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Keep Out Of Reach Of Children

→ Use

→ Warnings

→ You May Report

→ Directions

→ Inactive Ingredients

→ Package Label

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

Keep Out Of Reach Of Children

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)