SPL v1
SPL
SPL Set ID 3c447b68-c0f8-b2d4-e063-6294a90adc36
Route
TOPICAL
Published
Effective Date 2025-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octinoxate (7.5 g)
Inactive Ingredients
Corylus Avellana (hazelnut) Seed Oil Vitis Vinifera (grape) Seed Oil Daucus Carota Sativa (carrot) Seed Oil Paraffinum Liquidum .alpha.-tocopherol Acetate, Dl- Theobroma Cacao (cocoa) Seed Butter Parfumidine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-05
Description

Paraffinum Liquidum, Daucus Carota Sativa Seed Oil, Theobroma Cacao Seed Butter, Corylus Avellana Seed Oil, Parfum, Tocopheryl Acetate, Vitis Vinifera Seed Oil.

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Paraffinum Liquidum, Daucus Carota Sativa Seed Oil, Theobroma Cacao Seed Butter, Corylus Avellana Seed Oil, Parfum, Tocopheryl Acetate, Vitis Vinifera Seed Oil.

Uses

Helps prevent sunburn

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

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

Section 51945-4

Warning

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.

Direction

Apply generously 15 minutes before sun exposure.

Reapply

Protect this Product from excessive heat and direct sun

May stain some fabrics

– After 80 minutes of swimming or sweating.

– Immediately after towel drying.

– At least every 2 hours .

– Children under 6 months : Ask a doctor.

Active Ingredients

Avobenzone 3.0%

Octinoxate 7.5%

Inactive Ingredients

Paraffinum Liquidum, Daucus Carota

Sativa Seed Oil, Theobroma Cacao Seed Butter, Corylus Avellana

Seed Oil, Parfum, Tocopheryl Acetate, Vitis Vinifera Seed Oil.

Other Safety Information

Stop use and ask a doctor if:

Rash occurs.

Keep Out of Reach of Children

If Product is swallowed , get medical help or contact a

Poison Control Center right away.

Structured Label Content

Uses

Helps prevent sunburn

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

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

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warning

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.

Direction

Apply generously 15 minutes before sun exposure.

Reapply

Protect this Product from excessive heat and direct sun

May stain some fabrics

– After 80 minutes of swimming or sweating.

– Immediately after towel drying.

– At least every 2 hours .

– Children under 6 months : Ask a doctor.

Active Ingredients

Avobenzone 3.0%

Octinoxate 7.5%

Inactive Ingredients

Paraffinum Liquidum, Daucus Carota

Sativa Seed Oil, Theobroma Cacao Seed Butter, Corylus Avellana

Seed Oil, Parfum, Tocopheryl Acetate, Vitis Vinifera Seed Oil.

Other Safety Information

Stop use and ask a doctor if:

Rash occurs.

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:45.511990 · Updated: 2026-03-14T23:09:42.602872