Otc - Active Ingredient
ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00% [] AVOBENZONE 3.00% [] HOMOSALATE 2.90% [] OCTOCRYLENE 2.70%
Suntints
FDA Label NDC 40046-0034
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 Suntints (NDC 40046-0034). 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 otc - active ingredient, inactive ingredient, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
INACTIVE INGREDIENTS: OCTYLDODECANOL [] NEOPENTYL GLYCOL DIHEPTANOATE [] ETHYLCELLULOSE [] DIISOSTEARYL MALATE [] BUTYLOCTYL SALICYLATE [] DICAPRYLYL CARBONATE [] TOCOPHERYL ACETATE [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] DEXTRIN PALMITATE [] CALCIUM ALUMINUM BOROSILICATE [] CALCIUM SODIUM BOROSILICATE [] CAPRYLYL GLYCOL [] HEXYLENE GLYCOL [] SILICA [] TIN OXIDE [] LINOLEIC ACID [] HYDROGENATED DILINOLEYL ALCOHOL [] VANILLIN [] PHENOXYETHANOL [] [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090) [] CARMINE (CI 75470) [] RED 6 (CI 15850) [] RED 7 LAKE (CI 15850) [] RED 28 LAKE (CI 45410) [] RED 30 LAKE (CI 73360) [] RED 33 LAKE (CI 17200) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 6 LAKE (CI 15985)]
Warnings
WARNING: STOP USE IF IRRITATION OCCURS.
Package Label.Principal Display Panel
MAC
SUNTINTS SPF 20
LIQUID BALM
10 ML/ .33 FL OZ LIQ
MAKE UP ART COSMETICS, DIST
NY,NY 10022
Folding Carton (Mc15 Page 1)
* Please review the disclaimer below.
