SPL v6
SPL
SPL Set ID ad6646c7-c6aa-4610-a0c7-ddd1ddd13cde
Route
TOPICAL
Published
Effective Date 2024-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.5 g) Oxybenzone (2 g) Octisalate (4 g) Octinoxate (7.5 g)
Inactive Ingredients
Water Cetostearyl Alcohol Glycerin Stearyl Stearate Myristyl Myristate Sodium Pyrrolidone Carboxylate Pentylene Glycol Garcinia Indica Seed Butter Polyoxyl 20 Cetostearyl Ether Bis-diglyceryl Polyacyladipate-2 Cyclomethicone Cetyl Alcohol Shea Butter Papaya Spanish Chestnut Glycyrrhiza Glabra Chondrus Crispus Carrageenan Soy Isoflavones Dimethiconol (100000 Cst) Gold Ceramide Ng Phenoxyethanol Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Trolamine Alkyl (c12-15) Benzoate Panthenol Biosaccharide Gum-4 Caprylyl Glycol .alpha.-tocopherol Acetate Ethylhexylglycerin Hexylene Glycol Edetate Trisodium Tribehenin Alcohol Peg-4 Laurate Peg-4 Dilaurate Polysorbate 80 Lecithin, Soybean Iodopropynyl Butylcarbamate Polyethylene Glycol 200 Palmitoyl Hexapeptide-12 Magnesium Potassium Aluminosilicate Fluoride Titanium Dioxide Ferrous Oxide Stannic Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-13

Description

Avobenzone 2.5%, Oxybenzone 2%, Octisalate 4%, Octinoxate 7.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.5%, Oxybenzone 2%, Octisalate 4%, Octinoxate 7.5%

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 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

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

Direction

• 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

Questions?

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

Product Label

Active Ingredient

Avobenzone 2.5%, Oxybenzone 2%, Octisalate 4%, Octinoxate 7.5%

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin, Stearyl Stearate, Myristyl Myristate, Sodium PCA, Pentylene Glycol, Garcinia Indica Seed Butter, Ceteareth-20, Bis-Diglyceryl Polyacyladipate-2, Cyclomethicone, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Carica Papaya (Papaya) Fruit Extract, Castanea Sativa (Chestnut) Seed Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chondrus Crispus Extract, Soy Isoflavones, Dimethiconol, Gold, Ceramide NG, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, C12-15 Alkyl Benzoate, Panthenol, Biosaccharide Gum-4, Caprylyl Glycol, Tocopheryl Acetate, Ethylhexylglycerin, Hexylene Glycol, Trisodium EDTA, Smithsonite Extract, Tribehenin, Alcohol, PEG-4 Laurate, PEG-4 Dilaurate, Polysorbate 80, Lecithin, Iodopropynyl Butylcarbamate, PEG-4, PEG-10 Phytosterol, Palmitoyl Hexapeptide-12, Fragrance, Synthetic Fluorphlogopite, Titanium Dioxide, Iron Oxides, Tin Oxide


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 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

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

Direction

• 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

Questions?

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

Product Label (Product label)

Active Ingredient (Active ingredient)

Avobenzone 2.5%, Oxybenzone 2%, Octisalate 4%, Octinoxate 7.5%

Other Information (Other information)

protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Cetearyl Alcohol, Glycerin, Stearyl Stearate, Myristyl Myristate, Sodium PCA, Pentylene Glycol, Garcinia Indica Seed Butter, Ceteareth-20, Bis-Diglyceryl Polyacyladipate-2, Cyclomethicone, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Carica Papaya (Papaya) Fruit Extract, Castanea Sativa (Chestnut) Seed Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chondrus Crispus Extract, Soy Isoflavones, Dimethiconol, Gold, Ceramide NG, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, C12-15 Alkyl Benzoate, Panthenol, Biosaccharide Gum-4, Caprylyl Glycol, Tocopheryl Acetate, Ethylhexylglycerin, Hexylene Glycol, Trisodium EDTA, Smithsonite Extract, Tribehenin, Alcohol, PEG-4 Laurate, PEG-4 Dilaurate, Polysorbate 80, Lecithin, Iodopropynyl Butylcarbamate, PEG-4, PEG-10 Phytosterol, Palmitoyl Hexapeptide-12, Fragrance, Synthetic Fluorphlogopite, Titanium Dioxide, Iron Oxides, Tin Oxide


Advanced Ingredient Data


Raw Label Data

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