49a2430e-c15b-4610-e063-6294a90ac520

SPL v1
SPL
SPL Set ID 49a2430e-c15b-4610-e063-6294a90ac520
Route
topical
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (5 g) avobenzone (3 g) octisalate (6 g) octocrylene
Inactive Ingredients
aloe barbadensis leaf juice fragrance 13576 camellia sinensis leaf oil glycerin vitamin e polyethylene glycol succinate polyacrylate-13 phenoxyethanol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-01

Description

Sunscreen


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 occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Active ingredients

Octinoxate 5% .................................. Sunscreen

Octisalate 3% .................................. Sunscreen

Avobenzone 3% .................................. Sunscreen

Octocrylene 6% ................................ Sunscreen

Indications and Usage

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions),

decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

Apply liberally and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 months of age: ask a doctor.

Description

Sunscreen

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Water, Glycerin, Phenoxyethanol, Ethylhexylglycerin, Polyacrylate-13,

Polyisobutene, Polysorbate 20, Fragrance, Aloe Barbadensis Leaf Extract,

Camellia Sinensis Leaf Extract, Tocopherol

Section 51945-4

Section 55105-1

Sunscreen


Structured Label Content

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 occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient (55106-9)

Active ingredients

Octinoxate 5% .................................. Sunscreen

Octisalate 3% .................................. Sunscreen

Avobenzone 3% .................................. Sunscreen

Octocrylene 6% ................................ Sunscreen

Indications and Usage (34067-9)

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions),

decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Apply liberally and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 months of age: ask a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Water, Glycerin, Phenoxyethanol, Ethylhexylglycerin, Polyacrylate-13,

Polyisobutene, Polysorbate 20, Fragrance, Aloe Barbadensis Leaf Extract,

Camellia Sinensis Leaf Extract, Tocopherol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)