SPL v2
SPL
SPL Set ID 6d70e7c4-eddf-c161-e053-2991aa0ad324
Route
TOPICAL
Published
Effective Date 2018-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene (2 g) Oxybenzone (2.5 g)
Inactive Ingredients
Vinylpyrrolidone/hexadecene Copolymer Sodium Polyacrylate (8000 Mw) Trideceth-6 Xanthan Gum Acrylic Acid Trimethylsiloxysilicate (m/q 0.66) Edetic Acid Water Propylene Glycol Hydrated Silica Butyloctyl Salicylate 1,2-hexanediol Dimethyl Capramide Ethylhexyl Stearate Ethylhexylglycerin Butylated Hydroxytoluene Peg-100 Stearate Dimethicone Glyceryl Monostearate Benzyl Alcohol Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Caprylyl Trisiloxane Allantoin Calcium Pantothenate Caprylyl Glycol Glycerin Egg Phospholipids Garden Cress Sprout Maltodextrin Niacinamide Silicon Dioxide Sodium Ascorbyl Phosphate Aluminum Starch Octenylsuccinate Pyridoxine Hydrochloride .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-03-14

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 2%, Oxybenzone 2.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 2%, Oxybenzone 2.5%

Use

Helps prevent sunburn.

Label

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Stop use and ask a doctor if rash occurs.

Directions

Apply liberally 15 minutes before sun exposure. Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours.

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 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: ask a doctor.

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 2%, Oxybenzone 2.5%

Inactive Ingredients

1,2-Hexanediol, Behenyl Alcohol, BHT, Butyloctyl Salicylate, Calcium Pantothenate, Caprylyl Glycol, Caprylyl Methicone, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrated Silica, Lecithin, Lepidium Sativum Sprout Extract, Maltodextrin, Niacinamide, PEG-100 Stearate, Polyester-8, Pyridoxine HCl, Silica, Sodium Ascorbyl Phosphate, Sodium Polyacrylate, Sodium Starch Octenylsuccinate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Trideceth-6, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water, Xanthan Gum.

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

Helps prevent sunburn.

Label

Purpose

Sunscreen

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Stop use and ask a doctor if rash occurs.

Directions

Apply liberally 15 minutes before sun exposure. Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours.

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 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: ask a doctor.

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 2%, Oxybenzone 2.5%

Inactive Ingredients

1,2-Hexanediol, Behenyl Alcohol, BHT, Butyloctyl Salicylate, Calcium Pantothenate, Caprylyl Glycol, Caprylyl Methicone, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrated Silica, Lecithin, Lepidium Sativum Sprout Extract, Maltodextrin, Niacinamide, PEG-100 Stearate, Polyester-8, Pyridoxine HCl, Silica, Sodium Ascorbyl Phosphate, Sodium Polyacrylate, Sodium Starch Octenylsuccinate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Trideceth-6, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water, Xanthan Gum.

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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