SPL v1
SPL
SPL Set ID 577aea49-6092-3ede-e053-2991aa0a0283
Route
TOPICAL
Published
Effective Date 2016-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7 g) Amiloxate (3 g) Octisalate (1.5 g) Bemotrizinol (12.7 g) Titanium Dioxide
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-07-01
Description

Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Isoamyl p-Methoxycinnamate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Adenosine

Medication Information

Warnings and Precautions

For external use only.

Avoid contact with eyes. Not for human consumption.

Discontinue use if irritation occurs.

If irritation persists, consult a physician.

Please close the lid after use. If not, useful moisurizing and other contents can vaporize and the content can be ruduced.

Indications and Usage

Take the puff and press it into the cushion, then tap it all round your face to spread it evenly on your face.

Dosage and Administration

for external use only



Description

Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Isoamyl p-Methoxycinnamate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Adenosine

Section 50565-1

keep out or reach of the children

Section 51727-6

Water, Butylene Glycol, etc.

Section 51945-4

Section 55105-1

Sun block, Skin whitening, Wrinkle reducer

Section 55106-9

Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Isoamyl p-Methoxycinnamate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Adenosine

Structured Label Content

Indications and Usage (34067-9)

Take the puff and press it into the cushion, then tap it all round your face to spread it evenly on your face.

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)

For external use only.

Avoid contact with eyes. Not for human consumption.

Discontinue use if irritation occurs.

If irritation persists, consult a physician.

Please close the lid after use. If not, useful moisurizing and other contents can vaporize and the content can be ruduced.

Section 50565-1 (50565-1)

keep out or reach of the children

Section 51727-6 (51727-6)

Water, Butylene Glycol, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sun block, Skin whitening, Wrinkle reducer

Section 55106-9 (55106-9)

Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Isoamyl p-Methoxycinnamate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Adenosine

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:24.234822 · Updated: 2026-03-14T22:54:50.171645