Active Ingredients
OCTINOXATE 7.50%, OCTISALATE 2.00%, AVOBENZONE 1.50%
Tendertone Lip Balm Spf 12
FDA Label NDC 40046-0030
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 Tendertone Lip Balm Spf 12 (NDC 40046-0030). 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, otc - stop use, ingredients, other, principal display panel - 6 ml jar carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Stop Use
STOP USE IF IRRITATION OCCURS.
Ingredients
PETROLATUM, HYDROGENATED POLYISOBUTENE, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, ASTROCARYUM MURUMURU SEED BUTTER, COFFEA ARABICA (COFFEE) SEED EXTRACT, OLEA EUROPAEA (OLIVE) FRUIT EXTRACT, TRITICUM VULGARE (WHEAT BRAN) EXTRACT, TOCOPHERYL ACETATE, WATER, HYDROXYETHYLCELLULOSE, ETHYLCELLULOSE, CHOLESTEROL, PENTAERYTHRITYL ADIPATE/CAPRATE/CAPRYLATE/HEPTANOATE, HYDROGENATED DILINOLEYL ALCOHOL, OCTYLDODECANOL, CAPRYLYL GLYCOL, GLYCERYL STEARATE, LINOLEIC ACID, OLEIC ACID, PALMITIC ACID, POTASSIUM SULFATE, SILICA, CALCIUM SODIUM BOROSILICATE, CALCIUM ALUMINUM BOROSILICATE, ALUMINA, TIN OXIDE, HEXYLENE GLYCOL, BUTYLENE/ETHYLENE/STYRENE COPOLYMER, FRAGRANCE, BHT, PHENOXYETHANOL [+/- MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), BISMUTH OXYCHLORIDE (CI 77163), BLUE 1 (CI 42090), BLUE 1 LAKE (CI 42090), CARMINE (CI 75470), RED 6 (CI 15850), RED 7 (CI 15850), RED 7 LAKE (CI 15850), RED 28 LAKE (CI 45410), RED 30 (CI 73360), RED 33 (CI 17200), YELLOW 5 LAKE (CI 19140), YELLOW 10 (CI 47005), YELLOW 10 LAKE (CI 47005)] <ILN33874>
Other
DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
LONDON W1K 3BQ / MLWC
Principal Display Panel - 6 Ml Jar Carton
MAC
TENDERTONE
LIP BALM SPF 12
6 ML/0.2 US FL OZ e
Principal Display Panel (6 ML Jar Carton)
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