c3b265b1-ab84-4ea9-b283-c92f5a4cf461

SPL v10
SPL
SPL Set ID c3b265b1-ab84-4ea9-b283-c92f5a4cf461
Route
topical
Published
Effective Date 2025-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (10 g) octisalate (5 g) octocrylene
Inactive Ingredients
styrene/acrylamide copolymer (500000 mw) sucrose stearate ceric oxide aluminum oxide vinylpyrrolidone/eicosene copolymer glycerin ethylhexylglycerin ethylhexyl methoxycrylene butyloctyl salicylate phenylethyl alcohol polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) ceramide np butylene glycol polysorbate 60 phenoxyethanol dipropylene glycol potassium sorbate hydrogenated soybean lecithin avocado oil poly(methyl methacrylate; 450000 mw) water cocoa glyceryl monostearate peg-100 stearate hexylene glycol hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) lecithin, soybean maltodextrin squalane tocopherol xanthan gum medium-chain triglycerides caprylyl glycol hyaluronate sodium soybean sodium benzoate royal jelly sodium pyrrolidone carboxylate .alpha.-tocopherol acetate shea butter olive oil benzyl salicylate butylphenyl methylpropional linalool, (+/-)- hydroxycitronellal limonene, (+)- farnesol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-01-12 Until 2023-11-30
Purpose

Sunscreen

Description

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

Medication Information

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif 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 : 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, 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, Butyloctyl Salicylate, VP/Eicosene Copolymer, Polyester-8, Glyceryl Stearate,PEG-100 Stearate, Styrene/Acrylates Copolymer, Ethylhexyl Methoxycrylene,Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sucrose Stearate,Squalane, Phenoxyethanol, Caprylyl Glycol, Xanthan Gum, Polymethyl Methacrylate,Polysorbate 60, Potassium Sorbate, Royal Jelly Powder, Tocopheryl Acetate, Hexylene Glycol, Persea Gratissima (Avocado) Oil, Sodium PCA, Caprylic/Capric Triglyceride,Phytosterols, Cerium Oxide, Glycerin, Olea Europaea (Olive) Fruit Oil, Glycine Soja(Soybean) Seed Extract, Butyrospermum Parkii (Shea) Butter, Royal Jelly, Dipropylene Glycol, Lecithin, Alumina, Sodium Hyaluronate, Hydrogenated Lecithin, Butylene Glycol, Tocopherol, Phenethyl Alcohol, Tuber Magnatum Extract, Ceramide NP, Ethylhexylglycerin, Maltodextrin, Theobroma Cacao (Cocoa) Seed Extract, Tetrapeptide-45, Sodium Benzoate, Farnesol, Fragrance/Parfum, Benzyl Salicylate, Butylphenyl Methylpropional, Linalool, Hydroxycitronellal, Limonene

Description

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

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 10%

Structured Label Content

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif 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 : 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, 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, Butyloctyl Salicylate, VP/Eicosene Copolymer, Polyester-8, Glyceryl Stearate,PEG-100 Stearate, Styrene/Acrylates Copolymer, Ethylhexyl Methoxycrylene,Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sucrose Stearate,Squalane, Phenoxyethanol, Caprylyl Glycol, Xanthan Gum, Polymethyl Methacrylate,Polysorbate 60, Potassium Sorbate, Royal Jelly Powder, Tocopheryl Acetate, Hexylene Glycol, Persea Gratissima (Avocado) Oil, Sodium PCA, Caprylic/Capric Triglyceride,Phytosterols, Cerium Oxide, Glycerin, Olea Europaea (Olive) Fruit Oil, Glycine Soja(Soybean) Seed Extract, Butyrospermum Parkii (Shea) Butter, Royal Jelly, Dipropylene Glycol, Lecithin, Alumina, Sodium Hyaluronate, Hydrogenated Lecithin, Butylene Glycol, Tocopherol, Phenethyl Alcohol, Tuber Magnatum Extract, Ceramide NP, Ethylhexylglycerin, Maltodextrin, Theobroma Cacao (Cocoa) Seed Extract, Tetrapeptide-45, Sodium Benzoate, Farnesol, Fragrance/Parfum, Benzyl Salicylate, Butylphenyl Methylpropional, Linalool, Hydroxycitronellal, Limonene

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 10%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:24.053701 · Updated: 2026-03-14T23:07:07.673818