drug facts

drug facts
SPL v1
SPL
SPL Set ID 035f2500-7b38-4391-ad49-ded3eb8f2d56
Route
topical
Published
Effective Date 2013-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (2.6 mg)
Inactive Ingredients
cyclomethicone 5 glechoma hederacea flowering top houttuynia cordata flowering top plantago asiatica squalene sodium chloride dimethicone dipropylene glycol glycerin morus alba leaf ulmus davidiana root algeldrate panthenol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2013-08-26
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

houttuynia cordata ext, glechoma hederacea flower/leaf/stem ext, plantago asiatica ext, cyclopentasiloxane, butylene glycol, crprylic/capric triglyceride, dipropylene glycol, zinc oxide, morus alba leaf ext, ulmus davidiana root ext, cyclomethicone, squalane, peg-10 dimethicone, cetyl peg/ppg-10/1 dimethicone, sodium chloride, dimethicone/vinyl dimethicone crosspolymer, dimethicone, stearalkonium hectorite, propylene carbonate, aluminum hydroxide, aluminum stearate, caprylhydroxamic acid, caprylyl glycol, glycerin, 1,2-hexanediol, tocopheryl acetate, betaine, panthenol, ceramide 3, distearyldimonium chloride, sodium hyaluronate, beta glucan, bentonite, fragrance



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)

houttuynia cordata ext, glechoma hederacea flower/leaf/stem ext, plantago asiatica ext, cyclopentasiloxane, butylene glycol, crprylic/capric triglyceride, dipropylene glycol, zinc oxide, morus alba leaf ext, ulmus davidiana root ext, cyclomethicone, squalane, peg-10 dimethicone, cetyl peg/ppg-10/1 dimethicone, sodium chloride, dimethicone/vinyl dimethicone crosspolymer, dimethicone, stearalkonium hectorite, propylene carbonate, aluminum hydroxide, aluminum stearate, caprylhydroxamic acid, caprylyl glycol, glycerin, 1,2-hexanediol, tocopheryl acetate, betaine, panthenol, ceramide 3, distearyldimonium chloride, sodium hyaluronate, beta glucan, bentonite, fragrance



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: 2026-02-15T11:55:41.520541 · Updated: 2026-03-14T22:53:34.467425