Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 99bd822b-a37a-4cf6-8102-bdb4cfef954d
Route
CUTANEOUS
Published
Effective Date 2011-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (3.86 g) Octinoxate (1.5 g)
Inactive Ingredients
Water Cyclomethicone 5 Butylene Glycol Ceresin Boron Nitride Sodium Chloride Dimethicone Phenyl Trimethicone Sorbitan Olivate Silicon Dioxide Aluminum Hydroxide Stearic Acid Methylparaben Phenoxyethanol Aloe Vera Leaf Propylparaben Triethoxycaprylylsilane Talc

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-03-01
Description

Active ingredients: TITANIUM DIOXIDE 7.73%, OCTINOXATE 3%

Medication Information

Warnings and Precautions

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation appear.

Indications and Usage

Indication and usage:

After your daily skin care regimen, apply an even layer onto the face in upward and outward motions.

Dosage and Administration

Dosage and administration:

Dispense an ample amount and apply a thin layer onto the skin.

For maximum coverage, reapply the BB cream on hyper pigmentation areas.

Description

Active ingredients: TITANIUM DIOXIDE 7.73%, OCTINOXATE 3%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

WATER, CYCLOPENTASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLENE GLYCOL, POLYMETHYL METHACRYLATE, CERESIN, BORON NITRIDE, SORBITAN ISOSTEARATE, SODIUM CHLORIDE, DIMETHICONE, PHENYL TRIMETHICONE, SORBITAN OLIVATE, SILICA, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ALOE BARBADENSIS LEAF EXTRACT, TRIMETHYLSILOXYSILICATE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, TALC, METHYLPARABEN, PHENOXYETHANOL, PROPYLPARABEN, FRAGRANCE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), ULTRAMARINES (CI 77007), IRON OXIDES (CI 77491)

Section 51945-4

Section 55105-1

Purpose: UVA/UVB protection (SPF20 PA+)

Section 55106-9

Active ingredients: TITANIUM DIOXIDE 7.73%, OCTINOXATE 3%

Structured Label Content

Indications and Usage (34067-9)

Indication and usage:

After your daily skin care regimen, apply an even layer onto the face in upward and outward motions.

Dosage and Administration (34068-7)

Dosage and administration:

Dispense an ample amount and apply a thin layer onto the skin.

For maximum coverage, reapply the BB cream on hyper pigmentation areas.

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation appear.

Section 50565-1 (50565-1)

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients:

WATER, CYCLOPENTASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLENE GLYCOL, POLYMETHYL METHACRYLATE, CERESIN, BORON NITRIDE, SORBITAN ISOSTEARATE, SODIUM CHLORIDE, DIMETHICONE, PHENYL TRIMETHICONE, SORBITAN OLIVATE, SILICA, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ALOE BARBADENSIS LEAF EXTRACT, TRIMETHYLSILOXYSILICATE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, TALC, METHYLPARABEN, PHENOXYETHANOL, PROPYLPARABEN, FRAGRANCE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), ULTRAMARINES (CI 77007), IRON OXIDES (CI 77491)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: UVA/UVB protection (SPF20 PA+)

Section 55106-9 (55106-9)

Active ingredients: TITANIUM DIOXIDE 7.73%, OCTINOXATE 3%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:20.485626 · Updated: 2026-03-14T22:52:50.897919