Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9165b262-3418-4113-e053-2a95a90adaf1
Route
TOPICAL
Published
Effective Date 2019-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (9.5 g) Avobenzone (3 g) Homosalate (4.5 g) Octisalate
Inactive Ingredients
Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-08-31

Description

Octocrylene, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane


Medication Information

Warnings and Precautions

1. While using this product , if there

is any abnormal symptoms or side effect such as red spot,

swelling or itching, please consult with dermatologist.

2. Do not use in areas with wounds 3. Instructions for sto

-rage and usage. (i) Keep out of reach of infants and chil

-dren (ii) Store it in a place away from direct sunlight

Indications and Usage

Evenly apply a moderate amount

on areas exposed to sunlight during the last step of

your skincare routine. Carry it with you at all times

to frequently apply to necessary areas (face, body).

Dosage and Administration

for external use only

Description

Octocrylene, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

Section 50565-1

keep out of reach of the children

Section 51727-6

Dimethicone

Polyethylene

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Ozokerite

Acrylates Copolymer

Silica

Neopentyl Glycol Diheptanoate

Butyloctyl Salicylate

Cetyl Ethylhexanoate

HDI/Trimethylol Hexyllactone Crosspolymer

Polymethyl Methacrylate

Cetyl Alcohol

Tocopheryl Acetate

Caprylic/Capric Triglyceride

Citrus Aurantium Dulcis (Orange) Peel Oil

Geranium Maculatum Oil

Lavandula Angustifolia (Lavender) Oil

Citrus Aurantium Bergamia (Bergamot) Fruit Oil

Cymbopogon Martini Oil

Anthemis Nobilis Flower Oil

Section 51945-4

Section 55105-1

protects the skin from harmful UV rays (SPF50+ PA++++)

Section 55106-9

Octocrylene, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane


Structured Label Content

Indications and Usage (34067-9)

Evenly apply a moderate amount

on areas exposed to sunlight during the last step of

your skincare routine. Carry it with you at all times

to frequently apply to necessary areas (face, body).

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. While using this product , if there

is any abnormal symptoms or side effect such as red spot,

swelling or itching, please consult with dermatologist.

2. Do not use in areas with wounds 3. Instructions for sto

-rage and usage. (i) Keep out of reach of infants and chil

-dren (ii) Store it in a place away from direct sunlight

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Dimethicone

Polyethylene

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Ozokerite

Acrylates Copolymer

Silica

Neopentyl Glycol Diheptanoate

Butyloctyl Salicylate

Cetyl Ethylhexanoate

HDI/Trimethylol Hexyllactone Crosspolymer

Polymethyl Methacrylate

Cetyl Alcohol

Tocopheryl Acetate

Caprylic/Capric Triglyceride

Citrus Aurantium Dulcis (Orange) Peel Oil

Geranium Maculatum Oil

Lavandula Angustifolia (Lavender) Oil

Citrus Aurantium Bergamia (Bergamot) Fruit Oil

Cymbopogon Martini Oil

Anthemis Nobilis Flower Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

protects the skin from harmful UV rays (SPF50+ PA++++)

Section 55106-9 (55106-9)

Octocrylene, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane


Advanced Ingredient Data


Raw Label Data

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