SPL v2
SPL
SPL Set ID 4ff261e0-8fee-4e56-bcf5-d8f152d7f383
Route
TOPICAL
Published
Effective Date 2011-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.9 g) Octinoxate (4.5 g)
Inactive Ingredients
Talc Dimethicone Silicon Dioxide Boron Nitride Octyldodecyl Stearoyl Stearate Yeast Cupric Carbonate Caprylyl Glycol Gamma Oryzanol Alpha-tocopherol Acetate Calcium Carbonate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Hexylene Glycol Phenoxyethanol Sorbic Acid Bismuth Oxychloride Zinc Oxide Ferrosoferric Oxide Ferric Oxide Yellow Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2008-01-01

Description

ACTIVE INGREDIENTS: TITANIUM DIOXIDE, 4.9% [] OCTINOXATE 4.5%


Medication Information

Warnings and Precautions

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

Description

ACTIVE INGREDIENTS: TITANIUM DIOXIDE, 4.9% [] OCTINOXATE 4.5%

Section 51727-6

INACTIVE INGREDIENTS: TALC [] DIMETHICONE [] SILICA [] BORON NITRIDE [] OCTYLDODECYL STEAROYL STEARATE [] NYLON-12 [] POLYMETHYL METHACRYLATE [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] POLYGLYCERYL-3 DIISOSTEARATE [] POLYPERFLUOROMETHYLISOPROPYL ETHER [] METHICONE [] MALACHITE [] TOURMALINE [] ZEOLITE [] CAPRYLYL GLYCOL [] ORYZANOL [] TOCOPHERYL ACETATE [] CALCIUM CARBONATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] HEXYLENE GLYCOL [] PHENOXYETHANOL [] SORBIC ACID []  [+/- MICA [] BISMUTH OXYCHLORIDE (CI 77163) [] TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)]

Section 51945-4

PRINCIPAL DISPLAY PANEL:



skin color de la mer

LA MER

the treatment powder foundation

spf 15





nt wt. 0.35 oz./10 g



MAX HUBER RESEARCH LABS INC DISTR.

NEW YORK, NY 10022



Section 55106-9

ACTIVE INGREDIENTS: TITANIUM DIOXIDE, 4.9% [] OCTINOXATE 4.5%


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 51727-6 (51727-6)

INACTIVE INGREDIENTS: TALC [] DIMETHICONE [] SILICA [] BORON NITRIDE [] OCTYLDODECYL STEAROYL STEARATE [] NYLON-12 [] POLYMETHYL METHACRYLATE [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] POLYGLYCERYL-3 DIISOSTEARATE [] POLYPERFLUOROMETHYLISOPROPYL ETHER [] METHICONE [] MALACHITE [] TOURMALINE [] ZEOLITE [] CAPRYLYL GLYCOL [] ORYZANOL [] TOCOPHERYL ACETATE [] CALCIUM CARBONATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] HEXYLENE GLYCOL [] PHENOXYETHANOL [] SORBIC ACID []  [+/- MICA [] BISMUTH OXYCHLORIDE (CI 77163) [] TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)]

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL:



skin color de la mer

LA MER

the treatment powder foundation

spf 15





nt wt. 0.35 oz./10 g



MAX HUBER RESEARCH LABS INC DISTR.

NEW YORK, NY 10022



Section 55106-9 (55106-9)

ACTIVE INGREDIENTS: TITANIUM DIOXIDE, 4.9% [] OCTINOXATE 4.5%


Advanced Ingredient Data


Raw Label Data

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