Topcare Everyday Ultimate Sheer Sun Lotion Broad Spectrum Spf 70

Topcare Everyday Ultimate Sheer Sun Lotion Broad Spectrum Spf 70
SPL v2
SPL
SPL Set ID c51029f4-ede0-08ef-e053-2995a90aecaf
Route
TOPICAL
Published
Effective Date 2018-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octocrylene (70 mg) Octisalate (30 mg) Avobenzone (60 mg) Oxybenzone
Inactive Ingredients
Butyl Acrylate/c16-c20 Alkyl Methacrylate/methacrylic Acid/methyl Methacrylate Copolymer Edetate Disodium Trideceth-6 Trimethylsiloxysilicate (m/q 0.8-1.0) Xanthan Gum Ethylhexyl Stearate Caprylyl Trisiloxane Dimethicone Water Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer Silicon Dioxide Polysilicone-15 Glyceryl Stearate/peg-100 Stearate Sodium Polyacrylate (8000 Mw) Propylene Glycol Glycyrrhizinate Dipotassium White Wax Ethylhexylglycerin Phenoxyethanol Cetyl Dimethicone 45 Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-01

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 3.0% Octocrylene 7.0% Oxybenzone 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 3.0% Octocrylene 7.0% Oxybenzone 6.0%

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
Section 51945-4

TopCare Everyday Ultimate Sheer Sun Lotion Broad Spectrum SPF 70

3.0 FL OZ (89 mL)

-09

Warnings

​For external use only

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

  • 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

Do Not Use ​​
  • on damaged or broken skin.

Other Information

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 3.0%

Octocrylene 7.0%

Oxybenzone 6.0%

Inactive Ingredients

water, styrene/acrylates copolymer, dimethicone, acylates/C12-22 alkyl methacrylate copolymer, propylene glycol, xanthan gum, capryl methicone, polysilicone-15, cetyl dimethicone, glyceryl stearate, PEG-100 stearate, beeswax, silica, dipotassium glycyrrhizate, trimethylsiloxysilicate, sodium polyacrylate, ethylhexyl stearate, trideceth-6, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, disodium EDTA, fragrance

Stop Use and Ask A Doctor
  • if rash occurs.​
When Using This Product​
  • keep out of eyes. Rinse with water to remove.
Keep Out of Reach of Children.

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


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
Section 51945-4 (51945-4)

TopCare Everyday Ultimate Sheer Sun Lotion Broad Spectrum SPF 70

3.0 FL OZ (89 mL)

-09

Purpose

Sunscreen

Warnings

​For external use only

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

  • 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

Do Not Use ​​ (Do not use ​​)
  • on damaged or broken skin.

Other Information (Other information)

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 3.0%

Octocrylene 7.0%

Oxybenzone 6.0%

Inactive Ingredients (Inactive ingredients)

water, styrene/acrylates copolymer, dimethicone, acylates/C12-22 alkyl methacrylate copolymer, propylene glycol, xanthan gum, capryl methicone, polysilicone-15, cetyl dimethicone, glyceryl stearate, PEG-100 stearate, beeswax, silica, dipotassium glycyrrhizate, trimethylsiloxysilicate, sodium polyacrylate, ethylhexyl stearate, trideceth-6, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, disodium EDTA, fragrance

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if rash occurs.​
When Using This Product​ (When using this product​)
  • keep out of eyes. Rinse with water to remove.
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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