protection 50 sport

protection 50 sport
SPL v2
SPL
SPL Set ID e9ace96a-7717-4f5a-8e1b-1f56f7498599
Route
topical
Published
Effective Date 2024-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (10 mg) octocrylene (5 mg) octisalate (3 mg) avobenzone
Inactive Ingredients
water butylene glycol safflower oil dimethicone methyl methacrylate/glycol dimethacrylate crosspolymer c15-19 alkane vinylpyrrolidone/eicosene copolymer silicon dioxide dimethyl capramide polyglyceryl-2 stearate phenoxyethanol peg-100 stearate glyceryl stearate se arachidyl alcohol potassium cetyl phosphate squalane docosanol xanthan gum carbomer interpolymer type a (allyl sucrose crosslinked) arachidyl glucoside benzyl alcohol glycyrrhizinate dipotassium ethylhexylglycerin tetrasodium glutamate diacetate sodium hydroxide anhydrous citric acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-08-05

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Warnings

For external use only.

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions ), helps decrease the risk of skin cancer and early skin aging caused by the sun.
Purpose

Sunscreen

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 help 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-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor.
Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Water/Aqua/Eau, Carthamus Tinctorius (Safflower) Oleosomes, Butylene Glycol, Dimethicone, Methyl Methacrylate Crosspolymer, C15-19 Alkane, VP/ Eicosene Copolymer, Silica, Dimethyl Capramide, Polyglyceryl-2 Stearate, Squalane, Dipotassium Glycyrrhizate, Arachidyl Glucoside, Glyceryl Stearate SE, PEG-100 Stearate, Arachidyl Alcohol, Potassium Cetyl Phosphate, Dimethicone Crosspolymer, Behenyl Alcohol, Xanthan Gum, Acrylates/C10- 30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Ethylhexylglycerin, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, Citric Acid, Phenoxyethanol.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Do Not Use
  • on damaged or broken skin.
Active Ingredients

Avobenzone (3.0%)

Octisalate (5.0%)

Homosalate (10.0%)

Octocrylene (10.0%)

Questions Or Comments

Call toll free 1-800-831-5150 in the US

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs.
Principal Display Panel 156 Ml Tube Carton

protection

50

sport

SPF

50

broad spectrum

80 minutes

water-resistant

5.3 US FL OZ / 156 mL ℮

dermalogica


Structured Label Content

Warnings

For external use only.

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions ), helps decrease the risk of skin cancer and early skin aging caused by the sun.
Purpose

Sunscreen

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 help 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-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor.
Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, Carthamus Tinctorius (Safflower) Oleosomes, Butylene Glycol, Dimethicone, Methyl Methacrylate Crosspolymer, C15-19 Alkane, VP/ Eicosene Copolymer, Silica, Dimethyl Capramide, Polyglyceryl-2 Stearate, Squalane, Dipotassium Glycyrrhizate, Arachidyl Glucoside, Glyceryl Stearate SE, PEG-100 Stearate, Arachidyl Alcohol, Potassium Cetyl Phosphate, Dimethicone Crosspolymer, Behenyl Alcohol, Xanthan Gum, Acrylates/C10- 30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Ethylhexylglycerin, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, Citric Acid, Phenoxyethanol.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Do Not Use (Do not use)
  • on damaged or broken skin.
Active Ingredients (Active ingredients)

Avobenzone (3.0%)

Octisalate (5.0%)

Homosalate (10.0%)

Octocrylene (10.0%)

Questions Or Comments (Questions or comments)

Call toll free 1-800-831-5150 in the US

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs.
Principal Display Panel 156 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 156 mL Tube Carton)

protection

50

sport

SPF

50

broad spectrum

80 minutes

water-resistant

5.3 US FL OZ / 156 mL ℮

dermalogica


Advanced Ingredient Data


Raw Label Data

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