SPL v2
SPL
SPL Set ID dd837518-4724-451e-818a-679617f7feca
Route
TOPICAL
Published
Effective Date 2016-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (.02 g) Homosalate (.04 g) Octisalate Octocrylene
Inactive Ingredients
Water Dimethicone Trisiloxane Isononyl Isononanoate Glycerin Cetyl Alcohol Steareth-21 Silicon Dioxide Peg-100 Stearate Phenoxyethanol Ethylhexylglycerin Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Styrene Sodium Divinylbenzene Ammonium Nonoxynol-4 Sulfate Propylene Glycol Myrtus Communis Leaf Xanthan Gum Vitamin A Palmitate Polysorbate 20 Allyl Acrylate Edetate Disodium Ascorbic Acid Sodium Hydroxide Tris-bht Mesitylene Hyaluronic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-04-15
Description

Active ingredients Avobenzone 2.0% 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 sun protection measures (see Directions), decreases the risk of skin cancer and and early aging caused by the sun
Dosage and Administration

Directions

  • apply liberally 15 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 sking 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, especially from 10 a.m. - 2 p.m.

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

Description

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

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, trisiloxane, isononyl isononanoate, glycerin,

cetyl alcohol, steareth-21, nylon-12, silica, stearyl alcohol, glyceryl stearate, PEG-100 stearate,

phenoxyethanol, ethylhexylglycerin, dimethicone crosspolymer, sodium styrene/acrylates/divinylbenzene

copolymer, ammonium nonoxynol-4 sulfate, fragrance, propylene glycol, myrtus communis extract,

xantan gum, retinyl palmitate, polysorbate 20, acrylates/C10-30 alkyl acrylate crosspolymer,

disodium EDTA, ascorbic acid, sodium hydroxide, BHT, hyaluronic acid

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Section 55106-9

Active ingredients

Avobenzone 2.0%

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 sun protection measures (see Directions), decreases the risk of skin cancer and and early aging caused by the sun
Dosage and Administration (34068-7)

Directions

  • apply liberally 15 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 sking 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, especially 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 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, trisiloxane, isononyl isononanoate, glycerin,

cetyl alcohol, steareth-21, nylon-12, silica, stearyl alcohol, glyceryl stearate, PEG-100 stearate,

phenoxyethanol, ethylhexylglycerin, dimethicone crosspolymer, sodium styrene/acrylates/divinylbenzene

copolymer, ammonium nonoxynol-4 sulfate, fragrance, propylene glycol, myrtus communis extract,

xantan gum, retinyl palmitate, polysorbate 20, acrylates/C10-30 alkyl acrylate crosspolymer,

disodium EDTA, ascorbic acid, sodium hydroxide, BHT, hyaluronic acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Avobenzone 2.0%

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: 2026-02-15T11:56:06.375663 · Updated: 2026-03-14T22:54:19.785916