SPL v1
SPL
SPL Set ID 3843ff02-2443-7780-e063-6294a90a655d
Route
TOPICAL
Published
Effective Date 2025-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Octinoxate (7.5 g) Octocrylene (1.86 g) Oxybenzone (3 g)
Inactive Ingredients
Butyrospermum Parkii (shea) Butter Triethanolamine Water Glycerin Glyceryl Stearate Peg-100 Stearate Aloe Barbadensis Leaf Juice Carbomer Tocophersolan Fragrance 13576 Edetate Disodium C12-15 Alkyl Benzoate Dimethicone Ethylhexylglycerin Cetyl Alcohol Phenoxyethanol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Helps prevent sunburn.


Medication Information

Warnings and Precautions

For external use only.

Sunburn alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for one week afterwards.

Do not use:

- on damaged or broken skin.

- as a sunscreen for sunbathing.

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.

Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Helps prevent sunburn.

Dosage and Administration

Apply Daily Body Lotion once daily or as directed by a doctor at least 15 minutes before sun exposure.

Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.

Description

Helps prevent sunburn.

Section 43683-2

deleted undefined photo

Section 50565-1

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

Section 51727-6

Water, Glycolic Acid, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Sodium Hydroxide, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Cyclotetrasiloxane, PEG-40 Stearate, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cetearyl Glucoside, Cetyl Alcohol, Cholesterol, Dimethiconol, Disodium EDTA, Laureth-7, Methylparaben, Phenoxyethanol, Polyacrylamide, Tocopheryl Acetate, Xanthan Gum.

Section 51945-4

Section 55105-1

Avobenzone 2% – Sunscreen

Octinoxate 7.5% – Sunscreen

Octocrylene 1.86% – Sunscreen

Oxybenzone 3% – Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

Dosage and Administration (34068-7)

Apply Daily Body Lotion once daily or as directed by a doctor at least 15 minutes before sun exposure.

Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.

Warnings and Precautions (34071-1)

For external use only.

Sunburn alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for one week afterwards.

Do not use:

- on damaged or broken skin.

- as a sunscreen for sunbathing.

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.

Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

Section 43683-2 (43683-2)

deleted undefined photo

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 51727-6 (51727-6)

Water, Glycolic Acid, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Sodium Hydroxide, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Cyclotetrasiloxane, PEG-40 Stearate, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cetearyl Glucoside, Cetyl Alcohol, Cholesterol, Dimethiconol, Disodium EDTA, Laureth-7, Methylparaben, Phenoxyethanol, Polyacrylamide, Tocopheryl Acetate, Xanthan Gum.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Avobenzone 2% – Sunscreen

Octinoxate 7.5% – Sunscreen

Octocrylene 1.86% – Sunscreen

Oxybenzone 3% – Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)