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SPL v1

SPL

SPL Set ID 400420ff-f4d0-f9fe-e063-6294a90a8d80

Route

TOPICAL

Published

Effective Date 2025-09-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (5 g) Ethylhexyl Salicylate (2.5 g)

Inactive Ingredients

Parfumidine Water Ethylhexyl Palmitate Simmondsia Chinensis (jojoba) Seed Oil Abies Alba Whole Dimethicone Silica Dimethyl Silylate Rosa Canina Fruit Oil Bisabolol .alpha.-tocopherol Acetate, Dl- Adeps Bovis Beeswax

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-09-30

Description

ETHYLHEXYL SALICYLATE ZINC OXIDE

Purpose

SUNSCREEN

Medication Information

Purpose

SUNSCREEN

Description

ETHYLHEXYL SALICYLATE ZINC OXIDE

Uses

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.

Section 51945-4

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

Warnings

For external use only

Do Not Use

Do not use on damaged or broken skin.

When Using

When using this product keep out of eyes.

Active Ingredients

ETHYLHEXYL SALICYLATE

ZINC OXIDE

Inactive Ingredients

ETHYLHEXYL PALMITATE

ADEPS BOVIS

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

OZOKERITE

CERA ALBA

DIMETHICONE

SILICA DIMETHYL SILYLATE

TOCOPHEROL

ROSA CANINA FRUIT OIL

PARFUM

BISABOLOL

WATER

Dosage & Administration

Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.

Keep Out of Reach of Children

Keep Out Of Reach Of Children

Structured Label Content

Uses

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.

Section 51945-4 (51945-4)

Purpose

SUNSCREEN

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

Warnings

For external use only

Do Not Use

Do not use on damaged or broken skin.

When Using

When using this product keep out of eyes.

Active Ingredients

ETHYLHEXYL SALICYLATE

ZINC OXIDE

Inactive Ingredients (Inactive ingredients)

ETHYLHEXYL PALMITATE

ADEPS BOVIS

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

OZOKERITE

CERA ALBA

DIMETHICONE

SILICA DIMETHYL SILYLATE

TOCOPHEROL

ROSA CANINA FRUIT OIL

PARFUM

BISABOLOL

WATER

Dosage & Administration (Dosage & administration)

Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep Out Of Reach Of Children

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "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.", "Purpose": "SUNSCREEN", "Stop Use": "Rinse with wate to remove. Stop use and ask doctor if rash occurs.", "Warnings": "For external use only", "Do Not Use": "Do not use on damaged or broken skin.", "When Using": "When using this product keep out of eyes.", "Active Ingredients": "ETHYLHEXYL SALICYLATE ZINC OXIDE", "Inactive ingredients": "ETHYLHEXYL PALMITATE ADEPS BOVIS SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL OZOKERITE CERA ALBA DIMETHICONE SILICA DIMETHYL SILYLATE TOCOPHEROL ROSA CANINA FRUIT OIL PARFUM BISABOLOL WATER", "Dosage & administration": "Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.", "Keep Out Of Reach Of Children": "Keep Out Of Reach Of Children"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:07.761209 · Updated: 2026-03-14T23:10:21.394156