Active Ingredient
OCTINOXATE 7.50%
Mac
FDA Label NDC 40046-0055
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Makeup Art Cosmetics for the product Mac (NDC 40046-0055). 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 ingredient, ingredients, otc - when using, otc - stop use, otc - keep out of reach of children, other, principal display panel - 50 ml bottle carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ingredients
WATER\AQUA\EAU, DIMETHICONE, SILICA, CETYL DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL, POLYDECENE, GLYCERYL DILAURATE, ISOSTEARIC ACID, TROMETHAMINE, TOCOPHERYL ACETATE, SODIUM HYALURONATE, SUCROSE, HYDROGENATED LECITHIN, CAFFEINE, LINOLEIC ACID, XANTHAN GUM, CELLULOSE GUM, CHOLESTEROL, POLYETHYLENE, MAGNESIUM ALUMINUM SILICATE, PEG-9 DIMETHICONE, ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, HEXYLENE GLYCOL, TETRADIBUTYL PENTAERITHRITYL HYDROXYHYDROCINNAMATE, STEARETH-21, STEARETH-2, STEARIC ACID, POLYPERFLUOROMETHYLISOPROPYL ETHER, TETRASODIUM EDTA, BENZOIC ACID, DEHYDROACETIC ACID, PHENOXYETHANOL [+/- MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), CHROMIUM OXIDE GREENS (CI 77288)] <ILN32363>
Otc - When Using
KEEP OUT OF EYES.
Otc - Stop Use
STOP USE IF IRRITATION OCCURS.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Other
DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7,
LONDON W1K 3BQ. / M3H2
Principal Display Panel - 50 Ml Bottle Carton
M•A•C
SELECT TINT SPF 15
50 ML/1.7 US FL OZ e
Principal Display Panel (50 ML Bottle Carton)
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