SPL v1
SPL
SPL Set ID eac95a67-c877-443b-8e96-537f92c5c9cf
Route
TOPICAL
Published
Effective Date 2016-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octisalate (2.0 g) Oxybenzone (4.0 g) Titanium Dioxide (2.5 g)
Inactive Ingredients
Water Cetostearyl Alcohol Xanthan Gum Alkyl (c12-15) Benzoate Myristyl Propionate Propylene Glycol Glyceryl Stearate Citrate Edetate Disodium Iodopropynyl Butylcarbamate Dmdm Hydantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-06-25
Description

Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%, Titanium Dioxide 2.5%

Medication Information

Warnings and Precautions

WARNINGS:

Skin Cancer/Skin Aging Alert: Spending time in the sun

increase your risk of skin cancer and early skin aging.

this product had been shown only to prevent sunburn,

not skin cancer or skin aging.

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.

Indications and Usage

Uses: Helps prevent sunburn

Dosage and Administration

Directions

Apply generously & evenly before sun exposure. Reapply as

needed or after towel drying, swimming or sweating.

Ask doctor before using on children under 6 months.

Description

Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%, Titanium Dioxide 2.5%

Section 44425-7

Other information

Protect this product from excessive heat and direct sun

Section 50565-1

Keep out of reach of children. If product swallowed, get

medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

Water, Cetearyl Alcohol, Xanthan Gum,

C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol,

Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl

Butylcarbamate, DMDM Hydantoin, Fragrance

Section 51945-4

Section 53413-1

Questions or Comment? Call toll free 1-877-254-2281

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients

Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%,

Titanium Dioxide 2.5%

Structured Label Content

Indications and Usage (34067-9)

Uses: Helps prevent sunburn

Dosage and Administration (34068-7)

Directions

Apply generously & evenly before sun exposure. Reapply as

needed or after towel drying, swimming or sweating.

Ask doctor before using on children under 6 months.

Warnings and Precautions (34071-1)

WARNINGS:

Skin Cancer/Skin Aging Alert: Spending time in the sun

increase your risk of skin cancer and early skin aging.

this product had been shown only to prevent sunburn,

not skin cancer or skin aging.

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.

Section 44425-7 (44425-7)

Other information

Protect this product from excessive heat and direct sun

Section 50565-1 (50565-1)

Keep out of reach of children. If product swallowed, get

medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Cetearyl Alcohol, Xanthan Gum,

C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol,

Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl

Butylcarbamate, DMDM Hydantoin, Fragrance

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comment? Call toll free 1-877-254-2281

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%,

Titanium Dioxide 2.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:08.615131 · Updated: 2026-03-14T22:54:23.335310