Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2a817a3a-ed00-4007-959d-0f5c86175cb3
Route
CUTANEOUS
Published
Effective Date 2011-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (2.90 g) Octinoxate (1.50 g) Zinc Cation (0.88 g)
Inactive Ingredients
Water Cyclomethicone 5 Cyclomethicone 6 Butylene Glycol Glycerin Dicaprylyl Carbonate Dimethicone Mica Sorbitan Sesquioleate Acai Aluminum Hydroxide Stearic Acid Methylparaben Yellow Wax Chlorphenesin Triethoxycaprylylsilane Propylparaben Edetate Disodium Adenosine Cranberry Beach Strawberry Raspberry Blackberry Dendranthema Indicum Flower Green Tea Leaf Melissa Officinalis Leaf Thyme Jasminum Officinale Flower Rosemary Phenoxyethanol Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

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

Active ingredients: Titanium Dioxide 9.694 %, Octinoxate 5.00 %, Zinc Oxide 2.94%

Medication Information

Warnings and Precautions

Warnings:

For external use only.

Avoid contact with eyes. Do not swallow.

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 9.694 %, Octinoxate 5.00 %, Zinc Oxide 2.94%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, PEG-10 Dimethicone, Glycerin, Dicaprylyl Carbonate, Dimethicone, Caprylyl Methicone, Iron Oxides (CI 77492), Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Sesquioleate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Euterpe Oleracea Fruit Extract, Ozokerite, Mica (CI 77019), Dimethicone/Vinyl Dimethicone Crosspolymer, Iron Oxides (CI 77491), Aluminum Hydroxide, Stearic Acid, Methylparaben, Beeswax, Chlorphenesin, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Fragrance(Parfum), Propylparaben, Disodium EDTA, Adenosine, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Chrysanthemum Indicum Flower Extract, Camellia Sinensis Leaf Extract, Melissa Officinalis Leaf Extract, Aspalathus Linearis Extract, Thymus Vulgaris (Thyme) Extract, Jasminum Officinale (Jasmine) Extract, Rosmarinus Officinalis (Rosemary) Extract, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, Hydroxyethyl Ethylcellulose

Section 51945-4

Section 55105-1

Purpose: UVA/UVB protection

Section 55106-9

Active ingredients: Titanium Dioxide 9.694 %, Octinoxate 5.00 %, Zinc Oxide 2.94%

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. Do not swallow.

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, Cyclohexasiloxane, Butylene Glycol, PEG-10 Dimethicone, Glycerin, Dicaprylyl Carbonate, Dimethicone, Caprylyl Methicone, Iron Oxides (CI 77492), Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Sesquioleate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Euterpe Oleracea Fruit Extract, Ozokerite, Mica (CI 77019), Dimethicone/Vinyl Dimethicone Crosspolymer, Iron Oxides (CI 77491), Aluminum Hydroxide, Stearic Acid, Methylparaben, Beeswax, Chlorphenesin, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Fragrance(Parfum), Propylparaben, Disodium EDTA, Adenosine, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Chrysanthemum Indicum Flower Extract, Camellia Sinensis Leaf Extract, Melissa Officinalis Leaf Extract, Aspalathus Linearis Extract, Thymus Vulgaris (Thyme) Extract, Jasminum Officinale (Jasmine) Extract, Rosmarinus Officinalis (Rosemary) Extract, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, Hydroxyethyl Ethylcellulose

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: UVA/UVB protection

Section 55106-9 (55106-9)

Active ingredients: Titanium Dioxide 9.694 %, Octinoxate 5.00 %, Zinc Oxide 2.94%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:22.136178 · Updated: 2026-03-14T22:52:54.626056