SPL v1
SPL
SPL Set ID 17a5a5a8-c1a8-4542-912b-b501f4361b53
Route
TOPICAL
Published
Effective Date 2011-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.7 mL)
Inactive Ingredients
Water Cyclomethicone 5 Trimethoxycaprylylsilane Butylene Glycol Silicon Dioxide Phenyl Trimethicone Magnesium Sulfate, Unspecified Tribehenin Alpha-tocopherol Acetate Hyaluronate Sodium Glycerin Ethylhexylglycerin Polyglyceryl-4 Isostearate Dimethicone Laureth-7 Polymethylsilsesquioxane (11 Microns) Hexyl Laurate Carboxymethylcellulose Sodium Propylene Carbonate Aluminum Oxide Xanthan Gum Sorbic Acid Phenoxyethanol Chlorphenesin Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

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

ACTIVE INGREDIENT: TITANIUM DIOXIDE, 4.7%

Medication Information

Warnings and Precautions

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. IF IRRITATION PERSISTS, CONSULT A HEALTH PRACTITIONER. KEEP OUT OF REACH OF CHILDREN.

Description

ACTIVE INGREDIENT: TITANIUM DIOXIDE, 4.7%

Section 50567-7

DIRECTIONS: APPLY BEFORE SUN EXPOSURE.

Section 51727-6

INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] TRIMETHYLSILOXYSILICATE [] BUTYLENE GLYCOL [] TRIMETHYL PENTAPHENYL TRISILOXANE [] SILICA [] PHENYL TRIMETHICONE [] MAGNESIUM SULFATE [] POLYGLYCERYL-3 DIISOSTEARATE [] TRIBEHENIN [] PEG-10 DIMETHICONE [] BIS-PEG/PPG-14/14 DIMETHICONE [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] GLYCERIN [] ETHYLHEXYLGLYCERIN [] POLYGLYCERYL-4 ISOSTEARATE [] CETYL PEG/PPG-10/1 DIMETHICONE [] METHICONE [] TETRAMETHYL HEXAPHENYL TETRASILOXANE [] PHENYL METHICONE [] DIMETHICONE [] LAURETH-7 [] POLYMETHYLSILSESQUIOXANE [] HEXYL LAURATE [] DISTEARDIMONIUM HECTORITE [] CELLULOSE GUM [] PROPYLENE CARBONATE [] ALUMINA [] XANTHAN GUM [] DIMETHICONE SILYLATE [] SORBIC ACID [] PHENOXYETHANOL [] CHLORPHENESIN []  [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)]

Section 51945-4

PRINCIPAL DISPLAY PANEL



SMASHBOX

STUDIO SKIN

15 HOUR WEAR FOUNDATION

SPF 10





NET WT. 1 FL OZ/30 ML





Smashbox Beauty Cosmetics Inc,

Culver City, CA 90232



Section 55106-9

ACTIVE INGREDIENT: TITANIUM DIOXIDE, 4.7%

Structured Label Content

Warnings and Precautions (34071-1)

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. IF IRRITATION PERSISTS, CONSULT A HEALTH PRACTITIONER. KEEP OUT OF REACH OF CHILDREN.

Section 50567-7 (50567-7)

DIRECTIONS: APPLY BEFORE SUN EXPOSURE.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] TRIMETHYLSILOXYSILICATE [] BUTYLENE GLYCOL [] TRIMETHYL PENTAPHENYL TRISILOXANE [] SILICA [] PHENYL TRIMETHICONE [] MAGNESIUM SULFATE [] POLYGLYCERYL-3 DIISOSTEARATE [] TRIBEHENIN [] PEG-10 DIMETHICONE [] BIS-PEG/PPG-14/14 DIMETHICONE [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] GLYCERIN [] ETHYLHEXYLGLYCERIN [] POLYGLYCERYL-4 ISOSTEARATE [] CETYL PEG/PPG-10/1 DIMETHICONE [] METHICONE [] TETRAMETHYL HEXAPHENYL TETRASILOXANE [] PHENYL METHICONE [] DIMETHICONE [] LAURETH-7 [] POLYMETHYLSILSESQUIOXANE [] HEXYL LAURATE [] DISTEARDIMONIUM HECTORITE [] CELLULOSE GUM [] PROPYLENE CARBONATE [] ALUMINA [] XANTHAN GUM [] DIMETHICONE SILYLATE [] SORBIC ACID [] PHENOXYETHANOL [] CHLORPHENESIN []  [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)]

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL



SMASHBOX

STUDIO SKIN

15 HOUR WEAR FOUNDATION

SPF 10





NET WT. 1 FL OZ/30 ML





Smashbox Beauty Cosmetics Inc,

Culver City, CA 90232



Section 55106-9 (55106-9)

ACTIVE INGREDIENT: TITANIUM DIOXIDE, 4.7%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:16.132398 · Updated: 2026-03-14T22:52:41.001711