SPL v2
SPL
SPL Set ID 577a5cc2-5905-7777-e053-2a91aa0a2ba1
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 (13.3 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

Do not use on damaged or broken skin.



When using this product

• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.



Stop use if following symptoms occur. (Continuing in usage may increase symptoms, ask doctor.)



1) If any red spots, swelling, itching, or skin irritation develops.

2) If direct sunlight causes irritation

Keep out of reach of children

• Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control



Center right away.



Store at room temperature

Close lid after use – possibility of contamination may exists if displaced contents are replaced back to container.

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)

Do not use on damaged or broken skin.



When using this product

• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.



Stop use if following symptoms occur. (Continuing in usage may increase symptoms, ask doctor.)



1) If any red spots, swelling, itching, or skin irritation develops.

2) If direct sunlight causes irritation

Keep out of reach of children

• Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control



Center right away.



Store at room temperature

Close lid after use – possibility of contamination may exists if displaced contents are replaced back to container.

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

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