SPL v1
SPL
SPL Set ID dbf44ea9-1073-4a8f-b44b-2bf1a1b48081
Route
TOPICAL
Published
Effective Date 2017-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.478 g) Homosalate (4.72 g) Octisalate (2.36 1) Octocrylene
Inactive Ingredients
Water Dimethicone Trisiloxane Isononyl Isononanoate Glycerin Cetyl Alcohol Steareth-21 Nylon-12 Silicon Dioxide Stearyl Alcohol Glyceryl Monostearate Peg-100 Stearate Phenoxyethanol Ethylhexylglycerin Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Propylene Glycol Myrtus Communis Leaf Xanthan Gum Vitamin A Palmitate Polysorbate 20 Carboxypolymethylene Edetate Disodium Anhydrous Ascorbic Acid Sodium Hydroxide Butylated Hydroxytoluene Hyaluronic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-10-28
Description

Active ingredients Avobenzone, 2.1% Homosalate, 4.0% Octisalate, 4.0% Octocrylene, 2.0%

Medication Information

Warnings and Precautions

Warnings

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  •If used as directed

with other protection measures (see

Directions), decreases the risk of skin cancer and

early skin aging caused by the sun.

Dosage and Administration

Directions

•apply liberally 5 minutes before sun exposure

•reapply at least every 2 hours

•use water resistant sunscreen if swimming or

sweating.

•children under 6 months of age: ask a doctor.

•Sun Protection Measures: spending time in the sun

increases your risk of skin cancer and early skin aging. To

decrease this risk, regularly use a sunscreen with a Broad

Spectrum SPF value of 15 or higher and other sun

protection measures including:

   •limit time in the sun, specially from 10 a.m. - 2 p.m.

   •wear long-sleeved shirts, pants, hats and sunglasses.

Description

Active ingredients Avobenzone, 2.1% Homosalate, 4.0% Octisalate, 4.0% Octocrylene, 2.0%

Section 43685-7

WARNINGS: FOR EXTERNAL USE ONLY.

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE

THOROUGHLY WITH WATER. IF IRRITATION OR RASH OCCURS,

DISCONTINUE USE. KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, SEEK MEDICAL ATTENTION OR CONTACT  POISON

CONTROL CENTER RIGHT AWAY.

Section 44425-7

Other information  •protect the product in this

container from excessive heat and direct sun.

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

Inactive ingredients  Water, Dimethicone,

Trisiloxanane, Isononyl Isononanoate, Glycerin, Cetyl Alcohol,

Steareth-21, Nylon-12, Silica, Stearyl Alcohol, Glyceryl Stearate,

PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin,

Dimethicone Crosspolymer, Fragrance, Propylene Glycol,

Myrtus Communis Extract, Xanthan Gum, Retinyl Palmitate, Polysorbate 20, Carbomer,

Disodium EDTA, Ascorbic Acid, Sodium Hydroxide, ,BHT, Hyaluronic Acid.

Section 51945-4

Section 53413-1

QUESTIONS OR COMMENTS?

call 1-800-925-4733

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredients

Avobenzone, 2.1%

Homosalate, 4.0%

Octisalate, 4.0%

Octocrylene, 2.0%

Structured Label Content

Indications and Usage (34067-9)

Uses  •helps prevent sunburn  •If used as directed

with other protection measures (see

Directions), decreases the risk of skin cancer and

early skin aging caused by the sun.

Dosage and Administration (34068-7)

Directions

•apply liberally 5 minutes before sun exposure

•reapply at least every 2 hours

•use water resistant sunscreen if swimming or

sweating.

•children under 6 months of age: ask a doctor.

•Sun Protection Measures: spending time in the sun

increases your risk of skin cancer and early skin aging. To

decrease this risk, regularly use a sunscreen with a Broad

Spectrum SPF value of 15 or higher and other sun

protection measures including:

   •limit time in the sun, specially from 10 a.m. - 2 p.m.

   •wear long-sleeved shirts, pants, hats and sunglasses.

Warnings and Precautions (34071-1)

Warnings

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 43685-7 (43685-7)

WARNINGS: FOR EXTERNAL USE ONLY.

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE

THOROUGHLY WITH WATER. IF IRRITATION OR RASH OCCURS,

DISCONTINUE USE. KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, SEEK MEDICAL ATTENTION OR CONTACT  POISON

CONTROL CENTER RIGHT AWAY.

Section 44425-7 (44425-7)

Other information  •protect the product in this

container from excessive heat and direct sun.

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)

Inactive ingredients  Water, Dimethicone,

Trisiloxanane, Isononyl Isononanoate, Glycerin, Cetyl Alcohol,

Steareth-21, Nylon-12, Silica, Stearyl Alcohol, Glyceryl Stearate,

PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin,

Dimethicone Crosspolymer, Fragrance, Propylene Glycol,

Myrtus Communis Extract, Xanthan Gum, Retinyl Palmitate, Polysorbate 20, Carbomer,

Disodium EDTA, Ascorbic Acid, Sodium Hydroxide, ,BHT, Hyaluronic Acid.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

QUESTIONS OR COMMENTS?

call 1-800-925-4733

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Avobenzone, 2.1%

Homosalate, 4.0%

Octisalate, 4.0%

Octocrylene, 2.0%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.174840 · Updated: 2026-03-14T22:54:54.026912