SPL v1
SPL
SPL Set ID adb00a53-eb6c-22f2-e053-2995a90af52e
Route
TOPICAL
Published
Effective Date 2020-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (4.5 g) Octisalate (2 g) Avobenzone (1.5 g) Bemotrizinol (1.75 g) Octocrylene (1 g) Ethylhexyl Triazone
Inactive Ingredients
Water Alcohol Dimethicone Caprylyl Glycol Allantoin Polysorbate 80 Butylene Glycol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-20

Description

Avobenzone, Bemotrizinol, Ethylhexyl Triazone, Homosalate, Octisalate, Octocrylene


Medication Information

Warnings and Precautions

For external use only

Do not use on damaged or broken skin

When using this product

*Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if 

*rash or irritation develops and lasts

Keep our of reach of children.

If product is swallowed, get medical help or contact Poison Control Center

*Please read the "Directions", "Warnings", and "Other Information" carefully before use

Indications and Usage

Apply liberally and evenly to all exposed areas before sun exposure and as needed

Children under 6 months of age: ask a doctor

Dosage and Administration

For topical use only

Description

Avobenzone, Bemotrizinol, Ethylhexyl Triazone, Homosalate, Octisalate, Octocrylene

Section 51727-6

Water, Propanediol, Alcohol, Coco-Caprylate/Caprate, Pentylene Glycol, Dimethicone, Silica, Methyl Methacrylate Crosspolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Pullulan, Laureth-7, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Isohexadecane, Tromethamine, Caprylyl Glycol, Allantoin, Tocopheryl Acetate, Polysorbate 80, Ethylhexylglycerin, Disodium EDTA, Sorbitan Oleate, Xanthan Gum, Hydrolyzed Hyaluronic Acid, Butylene Glycol, Glycerin, Psidium Guajava Leaf Extract, Camellia Sinensis Leaf Extract, Punica Granatum Fruit Extract, Ficus Carica (Fig) Fruit Extract, Rosa Centifolia Flower Extract, Codonopsis Lanceolata Root Extract, Glycine, Serine, Glutamic Acid, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, Histidine, Methionine, Cysteine, Fragrance, Limonene, Linalool, Butylphenyl Methylpropional

Section 51945-4

Section 55105-1

Helps prevent sunburn.

Higher SPF gives more sunburn protection.

Section 55106-9

Avobenzone, Bemotrizinol, Ethylhexyl Triazone, Homosalate, Octisalate, Octocrylene

Keep Out of Reach of Children.

If product is swallowed, get medical

Help or contact a poison Control Center right away.


Structured Label Content

Indications and Usage (34067-9)

Apply liberally and evenly to all exposed areas before sun exposure and as needed

Children under 6 months of age: ask a doctor

Dosage and Administration (34068-7)

For topical use only

Warnings and Precautions (34071-1)

For external use only

Do not use on damaged or broken skin

When using this product

*Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if 

*rash or irritation develops and lasts

Keep our of reach of children.

If product is swallowed, get medical help or contact Poison Control Center

*Please read the "Directions", "Warnings", and "Other Information" carefully before use

Section 51727-6 (51727-6)

Water, Propanediol, Alcohol, Coco-Caprylate/Caprate, Pentylene Glycol, Dimethicone, Silica, Methyl Methacrylate Crosspolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Pullulan, Laureth-7, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Isohexadecane, Tromethamine, Caprylyl Glycol, Allantoin, Tocopheryl Acetate, Polysorbate 80, Ethylhexylglycerin, Disodium EDTA, Sorbitan Oleate, Xanthan Gum, Hydrolyzed Hyaluronic Acid, Butylene Glycol, Glycerin, Psidium Guajava Leaf Extract, Camellia Sinensis Leaf Extract, Punica Granatum Fruit Extract, Ficus Carica (Fig) Fruit Extract, Rosa Centifolia Flower Extract, Codonopsis Lanceolata Root Extract, Glycine, Serine, Glutamic Acid, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, Histidine, Methionine, Cysteine, Fragrance, Limonene, Linalool, Butylphenyl Methylpropional

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps prevent sunburn.

Higher SPF gives more sunburn protection.

Section 55106-9 (55106-9)

Avobenzone, Bemotrizinol, Ethylhexyl Triazone, Homosalate, Octisalate, Octocrylene

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical

Help or contact a poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)