SPL v1
SPL
SPL Set ID 03b0f2ee-526b-4513-b70a-2918ad322b5e
Route
TOPICAL
Published
Effective Date 2025-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (7 g) Ethylhexyl Salicylate (5 g) Octocrylene (10 g)
Inactive Ingredients
Water Stearyl Stearate Glycerin Cetostearyl Alcohol Myristyl Myristate C10-11 Isoparaffin Garcinia Indica Seed Butter Sodium Pyrrolidone Carboxylate Pentylene Glycol Cetyl Alcohol Bis-diglyceryl Polyacyladipate-2 Polyoxyl 20 Cetostearyl Ether Peg-12 Dimethicone (300 Cst) Shea Butter Papaya Phenoxyethanol Glyceryl Monostearate Peg-100 Monostearate Aluminum Starch Octenylsuccinate Ceteth-20 Phosphate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Alkyl (c12-15) Benzoate Panthenol Biosaccharide Gum-4 Glycyrrhiza Glabra (licorice) Root Powder Caprylyl Glycol Aminomethylpropanol .alpha.-tocopherol Acetate Dihexadecyl Phosphate Spanish Chestnut Ethylhexylglycerin Hexylene Glycol Edetate Trisodium Tribehenin Linalool, (+/-)- Alcohol Polysorbate 80 Ceramide Ng .beta.-citronellol, (r)- Lecithin, Soybean Limonene, (+)- Peg-10 Rapeseed Sterol Soy Isoflavones Palmitoyl Hexapeptide-12 Magnesium Potassium Aluminosilicate Fluoride Titanium Dioxide Ferric Oxide Red Stannic Oxide Gold

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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

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 doctor ifrash occurs
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 time in the sun, especially from 10 a.m. – 2 p.m.

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

Questions?

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

Product Label

Other Information

• protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients

Water, Stearyl Stearate, Glycerin, Cetearyl Alcohol, Myristyl Myristate, C10-11 Isoalkane, Garcinia Indica Seed Butter, Sodium PCA, Pentylene Glycol, Cetyl Alcohol, Bis-Diglyceryl Polyacyladipate-2, Ceteareth-20, PEG-12 Dimethicone, Butyrospermum Parkii (Shea) Butter, Carica Papaya (Papaya) Fruit Extract, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Fragrance, Ceteth-20

Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C12-15 Alkyl Benzoate, Panthenol, Biosaccharide Gum-4, Glycyrrhiza Glabra (Licorice) Root Extract, Caprylyl Glycol, Aminomethyl Propanol, Tocopheryl Acetate, Dicetyl Phosphate, Castanea Sativa (Chestnut) Seed Extract, Ethylhexylglycerin, Hexylene Glycol, Trisodium EDTA, Smithsonite Extract, Tribehenin, Linalool, Alcohol, Polysorbate 80, Ceramide NG, Citronellol, Lecithin, Limonene, PEG-10 Rapeseed Sterol, Soy Isoflavones, Palmitoyl Hexapeptide-12, Synthetic Fluorphlogopite, Titanium Dioxide/CI 77891, Iron Oxide/CI 77491, Tin Oxide, Gold


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

Purpose

Sunscreen

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 doctor ifrash occurs
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 time in the sun, especially from 10 a.m. – 2 p.m.

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

Questions?

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

Product Label (Product label)

Other Information (Other information)

• protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

Water, Stearyl Stearate, Glycerin, Cetearyl Alcohol, Myristyl Myristate, C10-11 Isoalkane, Garcinia Indica Seed Butter, Sodium PCA, Pentylene Glycol, Cetyl Alcohol, Bis-Diglyceryl Polyacyladipate-2, Ceteareth-20, PEG-12 Dimethicone, Butyrospermum Parkii (Shea) Butter, Carica Papaya (Papaya) Fruit Extract, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Fragrance, Ceteth-20

Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C12-15 Alkyl Benzoate, Panthenol, Biosaccharide Gum-4, Glycyrrhiza Glabra (Licorice) Root Extract, Caprylyl Glycol, Aminomethyl Propanol, Tocopheryl Acetate, Dicetyl Phosphate, Castanea Sativa (Chestnut) Seed Extract, Ethylhexylglycerin, Hexylene Glycol, Trisodium EDTA, Smithsonite Extract, Tribehenin, Linalool, Alcohol, Polysorbate 80, Ceramide NG, Citronellol, Lecithin, Limonene, PEG-10 Rapeseed Sterol, Soy Isoflavones, Palmitoyl Hexapeptide-12, Synthetic Fluorphlogopite, Titanium Dioxide/CI 77891, Iron Oxide/CI 77491, Tin Oxide, Gold


Advanced Ingredient Data


Raw Label Data

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