Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 3eb67c20-a1b6-3014-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2014-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.97 g) Octinoxate (7 g)
Inactive Ingredients
Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-09-01

Description

Ethylhexyl Methoxycinnamate, Titanium Dioxide


Medication Information

Warnings and Precautions
  • For external use only
  • When using this product

1. If any one of following symptoms occurs when using cosmetics, stop using it and consult a dermatologist.

A. red spot, swelling, itching, stimulus

B. symptoms mentioned above are caused by sunlight.

2. Do not apply on skin where there is wound, eczema, or irritation.

3. Storage and cautions for handling

A. Close stopper after using.

B. Keep out of reach of children.

C. Keep away from high or low temperature and direct sunlight.

4. This is not a medicinal product. Made of 100% cosmetic ingredients, it is a sensitive-skin care product for all skin types.

Indications and Usage

Apply proper amount to the skin

Dosage and Administration

for external use only

Description

Ethylhexyl Methoxycinnamate, Titanium Dioxide

Section 50565-1

keep out of reach of the children

Section 51727-6

Glycerin, Cyclomethicone, Cyclopentasiloxane, Isoamyl p-methoxycinnamate, Cyclohexasiloxane, Butylene Glycol, Cetyl Alcohol, Potassium Cetyl Phosphate, Glyceryl Stearate, Hydrogenated Polyisobutene, Bis-Ethylhexyloxyphenol Methoxyphenyl, Triazine, PEG-10 Dimethicone, Dimethicone, PEG-100 Stearate, etc.

Section 51945-4

Section 55105-1

Skin Protectant - Sunscreen

Section 55106-9

Ethylhexyl Methoxycinnamate, Titanium Dioxide


Structured Label Content

Indications and Usage (34067-9)

Apply proper amount to the skin

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)
  • For external use only
  • When using this product

1. If any one of following symptoms occurs when using cosmetics, stop using it and consult a dermatologist.

A. red spot, swelling, itching, stimulus

B. symptoms mentioned above are caused by sunlight.

2. Do not apply on skin where there is wound, eczema, or irritation.

3. Storage and cautions for handling

A. Close stopper after using.

B. Keep out of reach of children.

C. Keep away from high or low temperature and direct sunlight.

4. This is not a medicinal product. Made of 100% cosmetic ingredients, it is a sensitive-skin care product for all skin types.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Glycerin, Cyclomethicone, Cyclopentasiloxane, Isoamyl p-methoxycinnamate, Cyclohexasiloxane, Butylene Glycol, Cetyl Alcohol, Potassium Cetyl Phosphate, Glyceryl Stearate, Hydrogenated Polyisobutene, Bis-Ethylhexyloxyphenol Methoxyphenyl, Triazine, PEG-10 Dimethicone, Dimethicone, PEG-100 Stearate, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant - Sunscreen

Section 55106-9 (55106-9)

Ethylhexyl Methoxycinnamate, Titanium Dioxide


Advanced Ingredient Data


Raw Label Data

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