Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 449a6027-4d0d-40e1-af58-3553071d6fdf
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Octocrylene (70 mg)
Inactive Ingredients
Water Isononyl Isononanoate Glycerin Propanediol Alcohol Diisopropyl Sebacate Aluminum Starch Octenylsuccinate Styrene/acrylamide Copolymer (500000 Mw) Glyceryl Isostearate Pentylene Glycol Ribes Nigrum Seed Oil Mica .alpha.-tocopherol Acetate Phenoxyethanol Caffeine Peg-12 Dimethicone Peg-8 Laurate Magnesium Aspartate Trolamine Sunflower Oil Panthenol Xanthan Gum Zinc Gluconate Capryloyl Salicylic Acid Copper Gluconate Moringa Oleifera Seed Edetate Disodium Spanish Chestnut Rosa Canina Fruit Oil Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-25

Description

Avobenzone 3% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Octisalate 5% Octocrylene 7%

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 and evenly 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

Active Ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

Flammable Until Dry.

Do not use near fire, flame, or heat.

Inactive Ingredients

water, isononyl isononanoate, glycerin, propanediol, alcohol denat., diisopropyl sebacate, aluminum starch octenylsuccinate, styrene/acrylates

copolymer, glyceryl isostearate, pentylene glycol, ribes nigrum (black currant) seed oil, mica, tocopheryl acetate, phenoxyethanol, caffeine, PEG-12 dimethicone, PEG-8 laurate, magnesium aspartate, triethanolamine, helianthus annuus (sunflower) seed oil, ammonium acryloyldimethyltaurate/steareth-8 methacrylate copolymer, panthenol, xanthan gum, zinc gluconate, capryloyl salicylic acid, copper gluconate, moringa pterygosperma seed extract, disodium EDTA, castanea sativa (chestnut) seed extract, rosa canina fruit oil, titanium dioxide

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 and evenly 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

Active Ingredients (Active ingredients)

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame, or heat.

Inactive Ingredients (Inactive ingredients)

water, isononyl isononanoate, glycerin, propanediol, alcohol denat., diisopropyl sebacate, aluminum starch octenylsuccinate, styrene/acrylates

copolymer, glyceryl isostearate, pentylene glycol, ribes nigrum (black currant) seed oil, mica, tocopheryl acetate, phenoxyethanol, caffeine, PEG-12 dimethicone, PEG-8 laurate, magnesium aspartate, triethanolamine, helianthus annuus (sunflower) seed oil, ammonium acryloyldimethyltaurate/steareth-8 methacrylate copolymer, panthenol, xanthan gum, zinc gluconate, capryloyl salicylic acid, copper gluconate, moringa pterygosperma seed extract, disodium EDTA, castanea sativa (chestnut) seed extract, rosa canina fruit oil, titanium dioxide

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (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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