Mac

Mac
SPL v1
SPL
SPL Set ID f75ccb8e-9947-4921-9dc7-20816dee7372
Route
TOPICAL
Published
Effective Date 2012-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 mL) Octisalate (2 mL) Avobenzone (1.5 mL)
Inactive Ingredients
Petrolatum Astrocaryum Murumuru Seed Butter Arabica Coffee Bean Black Olive Wheat Bran Alpha-tocopherol Acetate Water Ethylcelluloses Cholesterol Octyldodecanol Caprylyl Glycol Glyceryl Monostearate Linoleic Acid Oleic Acid Palmitic Acid Potassium Sulfate Silicon Dioxide Aluminum Oxide Stannic Oxide Hexylene Glycol Butylated Hydroxytoluene Phenoxyethanol Mica Titanium Dioxide Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Bismuth Oxychloride Fd&c Blue No. 1 Cochineal D&c Red No. 6 D&c Red No. 7 D&c Red No. 28 D&c Red No. 30 D&c Red No. 33 Fd&c Yellow No. 5 D&c Yellow No. 10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2007-01-01
Description

OCTINOXATE 7.50%, OCTISALATE 2.00%, AVOBENZONE 1.50%

Medication Information

Description

OCTINOXATE 7.50%, OCTISALATE 2.00%, AVOBENZONE 1.50%

Section 42229-5

DIST. BY: MAKE-UP ART COSMETICS

TORONTO, ONTARIO, CANADA M5V 1R7

LONDON W1K 3BQ / MLWC

Section 50566-9

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>

Active Ingredients

OCTINOXATE 7.50%, OCTISALATE 2.00%, AVOBENZONE 1.50%

Principal Display Panel 6 Ml Jar Carton

MAC

TENDERTONE

LIP BALM SPF 12

6 ML/0.2 US FL OZ e

Structured Label Content

Section 42229-5 (42229-5)

DIST. BY: MAKE-UP ART COSMETICS

TORONTO, ONTARIO, CANADA M5V 1R7

LONDON W1K 3BQ / MLWC

Section 50566-9 (50566-9)

STOP USE IF IRRITATION OCCURS.

Ingredients (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>

Active Ingredients (ACTIVE INGREDIENTS)

OCTINOXATE 7.50%, OCTISALATE 2.00%, AVOBENZONE 1.50%

Principal Display Panel 6 Ml Jar Carton (PRINCIPAL DISPLAY PANEL - 6 ML Jar Carton)

MAC

TENDERTONE

LIP BALM SPF 12

6 ML/0.2 US FL OZ e

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:23.832334 · Updated: 2026-03-14T22:52:57.217022