drug facts

drug facts
SPL v1
SPL
SPL Set ID b2c02c98-83f2-4a68-b008-be315b4846b1
Route
topical
Published
Effective Date 2013-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (6 mg)
Inactive Ingredients
cyclomethicone 5 glechoma hederacea flowering top houttuynia cordata flowering top plantago asiatica cetostearyl alcohol octinoxate propanediol dipropylene glycol glycerin morus alba leaf ulmus davidiana root polysorbate 60 octocrylene

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2013-07-13
Description

titanium dioxide

Medication Information

Warnings and Precautions

do not apply to sensitive skin

store in a cool, dry place



Active Ingredient

titanium dioxide



Indications and Usage

gently spread a fair amount over face, neck, arm and etc esposed to UV rays



Dosage and Administration

for external use only



Description

titanium dioxide

Section 50565-1

keep out of reach of the children



Section 51727-6

Cyclopentasiloxane, Glechoma Hederacea Flower/Leaf/Stem Extract, Houttuynia Cordata Extract,  Plantago Asiatica Extract, Cetearyl Alcohol, Ethylhexyl Methoxycinnamate, Propanediol, Dipropylene Glycol, Glycerin, Morus Alba Leaf Extract, Ulmus Davidiana Root Extract, Butylene Glycol, Octocrylene, Polysorbate 60, Polyglyceryl-3 Methylglucose Distearate,  1,2-Hexanediol,  Alumina,  Betaine,  Hexyl Laurate,  Methicone,  PEG-10 Dimethicone,  Sorbitan Olivate,  Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine,  Glyceryl Stearate,  PEG-100 Stearate,  Fragrance, Magnesium Aluminum Silicate,  Caprylhydroxamic Acid,  Caprylyl Glycol,  Panthenol,  Triethanolamine,  Xanthan Gum,  Disodium EDTA,  Hydroxyethylcellulose,  Tocopheryl Acetate,  Beta-Glucan,  Butyrospermum Parkii (Shea Butter),  Ceramide 3, Squalane     　     





Section 51945-4
Section 55105-1

sun screen



Structured Label Content

Warnings and Precautions (34071-1)

do not apply to sensitive skin

store in a cool, dry place



Active Ingredient (55106-9)

titanium dioxide



Indications and Usage (34067-9)

gently spread a fair amount over face, neck, arm and etc esposed to UV rays



Dosage and Administration (34068-7)

for external use only



Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

Cyclopentasiloxane, Glechoma Hederacea Flower/Leaf/Stem Extract, Houttuynia Cordata Extract,  Plantago Asiatica Extract, Cetearyl Alcohol, Ethylhexyl Methoxycinnamate, Propanediol, Dipropylene Glycol, Glycerin, Morus Alba Leaf Extract, Ulmus Davidiana Root Extract, Butylene Glycol, Octocrylene, Polysorbate 60, Polyglyceryl-3 Methylglucose Distearate,  1,2-Hexanediol,  Alumina,  Betaine,  Hexyl Laurate,  Methicone,  PEG-10 Dimethicone,  Sorbitan Olivate,  Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine,  Glyceryl Stearate,  PEG-100 Stearate,  Fragrance, Magnesium Aluminum Silicate,  Caprylhydroxamic Acid,  Caprylyl Glycol,  Panthenol,  Triethanolamine,  Xanthan Gum,  Disodium EDTA,  Hydroxyethylcellulose,  Tocopheryl Acetate,  Beta-Glucan,  Butyrospermum Parkii (Shea Butter),  Ceramide 3, Squalane     　     





Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

sun screen



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:40.468968 · Updated: 2026-03-14T22:53:32.846368