Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 2cb40521-94ed-4e76-a4e2-de1c80155bd2
Route
TOPICAL
Published
Effective Date 2025-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (28.6 mg) Ethylhexyl Salicylate (49.5 mg) Octocrylene (97.5 mg)
Inactive Ingredients
Water Diisopropyl Adipate Ethylhexyl Methoxycrylene Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Euphorbia Cerifera (candelilla) Wax Silica Glycerin Panthenol Peg-40 Stearate Triacontanyl Pvp Phenoxyethanol Glyceryl Behenate/eicosadioate Ethylhexylglycerin Benzyl Alcohol Lavandula Angustifolia (lavender) Oil Simmondsia Chinensis (jojoba) Seed Oil Octyldodecanol Citrus Limon (lemon) Peel Oil Ammonium Acryloyldimethyltaurate/vp Copolymer Xanthan Gum Rosmarinus Officinalis (rosemary) Leaf Oil Methyl Glucose Sesquistearate .alpha.-tocopherol Acetate, D- Mentha Viridis (spearmint) Leaf Oil Tocopherol Dehydroacetic Acid Mentha Piperita (peppermint) Oil Soybean Oil Beta-carotene Carrot Linalool Limonene, (+)- Geraniol Citral Coumarin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

Avobenzone 2.86% Octisalate 4.95% Octocrylene 9.75%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.86% Octisalate 4.95% Octocrylene 9.75%

Uses
  • helps prevent sunburn.
  • 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

Warnings

For external use only.

Directions

For sunscreen use:

  • Apply generously 15 minutes before sun exposure.
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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, especially from 10 a.m.

- 2 p.m.

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

sunglasses

• children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin.

Other Information
  • Protect the product in this container from excessive heat and direct sun.
  • You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222.
Active Ingredients

Avobenzone 2.86%

Octisalate 4.95%

Octocrylene 9.75%

Inactive Ingredients

water, diisopropyl adipate, acrylates copolymer,

ethylhexyl methoxycrylene, capryloyl glycerin/sebacic

acid copolymer, euphorbia cerifera (candelilla)

wax, silica, glycerin, panthenol, PEG-40 stearate,

triacontanyl PVP, phenoxyethanol, glyceryl behenate,

ethylhexylglycerin, benzyl alcohol, lavandula

angustifolia (lavender) oil, simmondsia chinensis

(jojoba) seed oil, octyldodecanol, citrus limon (lemon)

peel oil, ammonium acryloyldimethyltaurate/VP

copolymer, xanthan gum, rosmarinus officinalis

(rosemary) leaf oil, methyl glucose sesquistearate,

tocopheryl acetate, mentha viridis (spearmint) leaf

oil, tocopherol, dehydroacetic acid, mentha piperita

(peppermint) oil, glycine soja (soybean) oil, beta-carotene, daucus carota sativa (carrot) root extract,

linalool, limonene, geraniol, citral, coumarin

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.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • helps prevent sunburn.
  • 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

Warnings

For external use only.

Directions

For sunscreen use:

  • Apply generously 15 minutes before sun exposure.
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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, especially from 10 a.m.

- 2 p.m.

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

sunglasses

• children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
  • You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222.
Active Ingredients (Active ingredients)

Avobenzone 2.86%

Octisalate 4.95%

Octocrylene 9.75%

Inactive Ingredients (Inactive ingredients)

water, diisopropyl adipate, acrylates copolymer,

ethylhexyl methoxycrylene, capryloyl glycerin/sebacic

acid copolymer, euphorbia cerifera (candelilla)

wax, silica, glycerin, panthenol, PEG-40 stearate,

triacontanyl PVP, phenoxyethanol, glyceryl behenate,

ethylhexylglycerin, benzyl alcohol, lavandula

angustifolia (lavender) oil, simmondsia chinensis

(jojoba) seed oil, octyldodecanol, citrus limon (lemon)

peel oil, ammonium acryloyldimethyltaurate/VP

copolymer, xanthan gum, rosmarinus officinalis

(rosemary) leaf oil, methyl glucose sesquistearate,

tocopheryl acetate, mentha viridis (spearmint) leaf

oil, tocopherol, dehydroacetic acid, mentha piperita

(peppermint) oil, glycine soja (soybean) oil, beta-carotene, daucus carota sativa (carrot) root extract,

linalool, limonene, geraniol, citral, coumarin

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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