SPL v1
SPL
SPL Set ID 607ff715-c197-4384-a81e-c4c64ead2975
Route
TOPICAL
Published
Effective Date 2011-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.5 mL)
Inactive Ingredients
Water Cyclomethicone 5 Butylene Glycol Steareth-21 Glyceryl Monostearate Dimethicone Isostearic Acid Tromethamine .alpha.-tocopherol Acetate, D- Lecithin, Soybean Cholesterol Ascorbyl Palmitate Hyaluronate Sodium Caffeine Aloe Vera Leaf Hydrogenated Soybean Lecithin Sucrose Sorbitol Silicon Dioxide Trehalose Magnesium Aluminum Silicate Carbomer Homopolymer Type C Steareth-2 Carboxymethylcellulose Sodium Palmitoyl Oligopeptide Xanthan Gum Caprylyl Glycol Stearic Acid Sodium Citrate Glycerin Edetate Disodium Hexylene Glycol Butylated Hydroxytoluene Phenoxyethanol Chlorphenesin Chloroxylenol Mica Titanium Dioxide Ferrosoferric Oxide Ferric Oxide Yellow Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2009-01-01
Description

ACTIVE INGREDIENT: OCTINOXATE, 3.5%

Medication Information

Warnings and Precautions

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

Description

ACTIVE INGREDIENT: OCTINOXATE, 3.5%

Section 50567-7

DIRECTIONS: AFTER CLEANSING, APPLY TO CLEAN SKIN WITH FINGERTIPS, SPONGE OR BRUSH

Section 51727-6

INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] BUTYLENE GLYCOL [] STEARETH-21 [] GLYCERYL STEARATE [] DIMETHICONE [] ISOSTEARIC ACID [] TROMETHAMINE [] TOCOPHERYL ACETATE [] LECITHIN [] CHOLESTEROL [] ASCORBYL PALMITATE [] SODIUM HYALURONATE [] CAFFEINE [] ALOE BARBADENSIS LEAF WATER [] HYDROGENATED LECITHIN [] SUCROSE [] SORBITOL [] SILICA [] TREHALOSE [] MAGNESIUM ALUMINUM SILICATE [] CARBOMER [] STEARETH-2 [] CELLULOSE GUM [] PVP [] PALMITOYL OLIGOPEPTIDE [] GLYCERYL POLYMETHACRYLATE [] METHYLDIHYDROJASMONATE [] XANTHAN GUM [] CAPRYLYL GLYCOL [] STEARIC ACID [] SODIUM CITRATE [] PEG-8 [] GLYCERIN [] DISODIUM EDTA [] HEXYLENE GLYCOL [] BHT [] PHENOXYETHANOL [] CHLORPHENESIN [] CHLOROXYLENOL []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)

Section 51945-4

PRINCIPAL DISPLAY PANEL:





MAC

STUDIO MOISTURE TINT



SPF 15







40 ML/1.3 US FL OZ









DISTR MAKE UP ART COSMETICS

TORONTO, ONTARIO, CANADA, M5V 1R7



















Section 55106-9

ACTIVE INGREDIENT: OCTINOXATE, 3.5%

Structured Label Content

Warnings and Precautions (34071-1)

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

Section 50567-7 (50567-7)

DIRECTIONS: AFTER CLEANSING, APPLY TO CLEAN SKIN WITH FINGERTIPS, SPONGE OR BRUSH

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] BUTYLENE GLYCOL [] STEARETH-21 [] GLYCERYL STEARATE [] DIMETHICONE [] ISOSTEARIC ACID [] TROMETHAMINE [] TOCOPHERYL ACETATE [] LECITHIN [] CHOLESTEROL [] ASCORBYL PALMITATE [] SODIUM HYALURONATE [] CAFFEINE [] ALOE BARBADENSIS LEAF WATER [] HYDROGENATED LECITHIN [] SUCROSE [] SORBITOL [] SILICA [] TREHALOSE [] MAGNESIUM ALUMINUM SILICATE [] CARBOMER [] STEARETH-2 [] CELLULOSE GUM [] PVP [] PALMITOYL OLIGOPEPTIDE [] GLYCERYL POLYMETHACRYLATE [] METHYLDIHYDROJASMONATE [] XANTHAN GUM [] CAPRYLYL GLYCOL [] STEARIC ACID [] SODIUM CITRATE [] PEG-8 [] GLYCERIN [] DISODIUM EDTA [] HEXYLENE GLYCOL [] BHT [] PHENOXYETHANOL [] CHLORPHENESIN [] CHLOROXYLENOL []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL:





MAC

STUDIO MOISTURE TINT



SPF 15







40 ML/1.3 US FL OZ









DISTR MAKE UP ART COSMETICS

TORONTO, ONTARIO, CANADA, M5V 1R7



















Section 55106-9 (55106-9)

ACTIVE INGREDIENT: OCTINOXATE, 3.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:16.061026 · Updated: 2026-03-14T22:52:41.001711