Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c0c6fcf3-0bff-49c4-bbb5-b2f1c0288549
Route
TOPICAL
Published
Effective Date 2010-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (0.075 mL) Enzacamene (0.05 mL) Titanium Dioxide (0.0249 mL) Avobenzone (0.03 mL) Zinc Oxide (0.01 mL)
Inactive Ingredients
Water Cyclomethicone 5 Dipropylene Glycol Glycerin Dimethicone Hexyl Laurate Sorbitan Olivate Sorbitan Sesquioleate Magnesium Sulfate, Unspecified Stearic Acid Hectorite Aluminum Hydroxide Phenoxyethanol Propylparaben Methylparaben Edetate Disodium

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2010-12-18
Description

active ingredients: Ethylhexyl methoxycinnamate, 4-methylbenzylidene camphor, butyl methoxydibenzoylmethane, titanium dioxide, zinc oxide

Medication Information

Warnings and Precautions
Avoid eye area. If contact occurs, rinse eyes thoroughly with water.

If  following abnormal symptoms (red specks, swelling, itching) occurs after use, stop use and ask doctor.
Indications and Usage
Apply daily, with or without make-up to exposed areas
Dosage and Administration
Apply daily, with or without make-up to exposed areas
Description

active ingredients: Ethylhexyl methoxycinnamate, 4-methylbenzylidene camphor, butyl methoxydibenzoylmethane, titanium dioxide, zinc oxide

Section 50565-1
keep out of reach of the children
Section 51727-6
inactive ingredient: water, cyclopentasiloxane, dipropylene glycol, glycerin, dimethicone, hexyl laurate, sorbitan olivate, sorbitan sesquioleate, magnesium sulfate, stearic acid, hectorite, aluminum hydroxide, phenoxyethanol, propylparaben, methylparaben, disodium EDTA, fragrance

Section 51945-4
Section 55105-1
Recommended for sensitive skin that needs virtually total sunblock protection
Section 55106-9
active ingredients: Ethylhexyl methoxycinnamate, 4-methylbenzylidene camphor, butyl methoxydibenzoylmethane, titanium dioxide, zinc oxide

Structured Label Content

Indications and Usage (34067-9)
Apply daily, with or without make-up to exposed areas
Dosage and Administration (34068-7)
Apply daily, with or without make-up to exposed areas
Warnings and Precautions (34071-1)
Avoid eye area. If contact occurs, rinse eyes thoroughly with water.

If  following abnormal symptoms (red specks, swelling, itching) occurs after use, stop use and ask doctor.
Section 50565-1 (50565-1)
keep out of reach of the children
Section 51727-6 (51727-6)
inactive ingredient: water, cyclopentasiloxane, dipropylene glycol, glycerin, dimethicone, hexyl laurate, sorbitan olivate, sorbitan sesquioleate, magnesium sulfate, stearic acid, hectorite, aluminum hydroxide, phenoxyethanol, propylparaben, methylparaben, disodium EDTA, fragrance

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Recommended for sensitive skin that needs virtually total sunblock protection
Section 55106-9 (55106-9)
active ingredients: Ethylhexyl methoxycinnamate, 4-methylbenzylidene camphor, butyl methoxydibenzoylmethane, titanium dioxide, zinc oxide

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:12.192806 · Updated: 2026-03-14T22:52:34.752454