Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4dbb36fe-9888-4806-8946-10cc0c81d270
Route
TOPICAL
Published
Effective Date 2011-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (6 mL) Titanium Dioxide (6.36 mL) Zinc Oxide (2.88 mL) Betaine (2 mL) Talc (0.684 mL)
Inactive Ingredients
Water Cyclomethicone Dipropylene Glycol Dimethicone Glycerin Mica Titanium Dioxide Aluminum Hydroxide Stearic Acid Magnesium Sulfate, Unspecified Triethoxycaprylylsilane Polyglyceryl-4 Isostearate Hexyl Laurate Phenoxyethanol Methylparaben Distearyldimonium Chloride Carex Humilis Root Ethylparaben Propylparaben Triethylhexanoin Maritime Pine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-08-23
Description

OCTINOXATE (6%) TITANIUM DIOXIDE (6.36%) ZINC OXIDE (2.88%) BETAINE (2%) TALC (0.684%)

Medication Information

Dosage and Administration

Dispense an adequate amount and apply evenly. (At the final stage of basic skincare, dispense an adequate amount and apply evenly to desired parts)

Description

OCTINOXATE (6%) TITANIUM DIOXIDE (6.36%) ZINC OXIDE (2.88%) BETAINE (2%) TALC (0.684%)

Section 50566-9

Discontinue use if sign of irritation or rash appear.

Section 50567-7
Avoid contact with eyes.
Section 51727-6
WATER, CYCLOMETHICONE, DIPROPYLENE GLYCOL, DIMETHICONE, GLYCERIN, MICA, TITANIUM DIOXIDE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, DISTEARYLDIMONIUM CHLORIDE, STEARIC ACID, CAREX HUMILIS ROOT, ETHYLPARABEN, PROPYLPARABEN, MICA, TRIETHYLHEXANOIN, MARITIME PINE

Section 51945-4
FACE IT HD PERFECT BB SPF30 PA++ 01







Section 55105-1

Provides high protection against sunburn and tanning.

Section 55106-9
OCTINOXATE (6%)

TITANIUM DIOXIDE (6.36%)

ZINC OXIDE (2.88%)

BETAINE (2%)

TALC (0.684%)

Structured Label Content

Dosage and Administration (34068-7)

Dispense an adequate amount and apply evenly. (At the final stage of basic skincare, dispense an adequate amount and apply evenly to desired parts)

Section 50566-9 (50566-9)

Discontinue use if sign of irritation or rash appear.

Section 50567-7 (50567-7)
Avoid contact with eyes.
Section 51727-6 (51727-6)
WATER, CYCLOMETHICONE, DIPROPYLENE GLYCOL, DIMETHICONE, GLYCERIN, MICA, TITANIUM DIOXIDE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, DISTEARYLDIMONIUM CHLORIDE, STEARIC ACID, CAREX HUMILIS ROOT, ETHYLPARABEN, PROPYLPARABEN, MICA, TRIETHYLHEXANOIN, MARITIME PINE

Section 51945-4 (51945-4)
FACE IT HD PERFECT BB SPF30 PA++ 01







Section 55105-1 (55105-1)

Provides high protection against sunburn and tanning.

Section 55106-9 (55106-9)
OCTINOXATE (6%)

TITANIUM DIOXIDE (6.36%)

ZINC OXIDE (2.88%)

BETAINE (2%)

TALC (0.684%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:19.533877 · Updated: 2026-03-14T22:52:49.153069