29b3ee35-e849-4427-a455-37d92c4b995c

SPL v10
SPL
SPL Set ID 29b3ee35-e849-4427-a455-37d92c4b995c
Route
topical
Published
Effective Date 2025-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (10 g) octisalate (5 g) octocrylene (7 g)
Inactive Ingredients
carbomer copolymer type b (allyl pentaerythritol crosslinked) kiwi fruit oil alcohol allantoin aluminum starch octenylsuccinate arachidyl alcohol arachidyl glucoside arginine docosanol benzyl alcohol levomenol butylene glycol shea butter chlorphenesin coconut cyclomethicone 5 dipropylene glycol edetate disodium ethylhexylglycerin glycerin glyceryl monostearate hydrogenated soybean lecithin lauroyl lysine lecithin, soybean maltodextrin moringa oleifera leaf peg-100 stearate phenylethyl alcohol polygonum aviculare top royal jelly sodium ascorbyl phosphate sophora flavescens root water benzyl salicylate hydroxycitronellal limonene, (+)- linalool, (+/-)- 2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-08-22
Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%

Medication Information

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

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.
Purpose

Sunscreen

Directions
  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours.
  • use a 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 your time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Other Information
  • protect this product from excessive heat and direct sun
Inactive Ingredients

Water, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Ethylhexylglycerin, Benzyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Bisabolol, Behenyl Alcohol, Cyclopentasiloxane, Lauroyl Lysine, Fragrance, Arachidyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Allantoin, Arginine, Chlorphenesin, Acrylates/Dimethicone Copolymer, Royal Jelly Powder, Glycerin, Benzyl Salicylate, Butyrospermum Parkii (Shea) Butter, Dipropylene Glycol, Sodium Ascorbyl Phosphate, Lecithin, Hydroxycitronellal, Limonene, Hydrogenated Lecithin, Linalool, Royal Jelly, Polygonum Aviculare Extract, Phenethyl Alcohol, Cocos Nucifera (Coconut) Fruit Extract, Butylene Glycol, Actinidia Chinensis (Kiwi) Fruit Water, Moringa Oleifera Leaf Extract, Maltodextrin, Tetrapeptide-45, Alcohol, Sophora Flavescens Root Extract

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%

Questions?

Call 1-800-551-2345 or visit www.jafra.com

Section 50565-1

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

Product Label

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Structured Label Content

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

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.
Purpose

Sunscreen

Directions
  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours.
  • use a 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 your time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Other Information (Other information)
  • protect this product from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

Water, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Ethylhexylglycerin, Benzyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Bisabolol, Behenyl Alcohol, Cyclopentasiloxane, Lauroyl Lysine, Fragrance, Arachidyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Allantoin, Arginine, Chlorphenesin, Acrylates/Dimethicone Copolymer, Royal Jelly Powder, Glycerin, Benzyl Salicylate, Butyrospermum Parkii (Shea) Butter, Dipropylene Glycol, Sodium Ascorbyl Phosphate, Lecithin, Hydroxycitronellal, Limonene, Hydrogenated Lecithin, Linalool, Royal Jelly, Polygonum Aviculare Extract, Phenethyl Alcohol, Cocos Nucifera (Coconut) Fruit Extract, Butylene Glycol, Actinidia Chinensis (Kiwi) Fruit Water, Moringa Oleifera Leaf Extract, Maltodextrin, Tetrapeptide-45, Alcohol, Sophora Flavescens Root Extract

Questions?

Call 1-800-551-2345 or visit www.jafra.com

Section 50565-1 (50565-1)

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

Product Label (Product label)

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:22.203227 · Updated: 2026-03-14T23:13:25.872506