Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 434a1cc9-b4a9-42ac-83b1-8430285c4c7b
Route
TOPICAL
Published
Effective Date 2016-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (13 g) Octisalate (5 g) Octocrylene (6 g) Oxybenzone
Inactive Ingredients
Water Neopentyl Glycol Diheptanoate Propylene Glycol Benzyl Alcohol Chlorphenesin Trolamine Edetate Disodium Oleth-3 Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-01-05

Description

Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 5.0%, Oxybenzone 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 5.0%, 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
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



    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 broad spectrum SPF of 15 or higher and other sun protection measures including:

  •  limit time in sun, especially from 10.00 a.m. - 2.00 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information
  • protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 5.0%, Oxybenzone 6.0%

Inactive Ingredients

Water, Neopentyl Glycol Diheptanoate, Styrene/Acrylates Copolymer, Propylene Glycol,Polyglyceryl-3 Methylglucose Distearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer,Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Disodium EDTA, Tocopherol, Oleth-3, Chlorphenesin, Fragrance.

Questions Or Comments?

Call 1-800-WALGREENS (1-800-925-4733)

Principal Display Panel

NDC 0363-4734-27

BONUS SIZE

Well at Walgreens

25% MORE FREE

WALGREENS PHARMACIST RECOMMENDED*

SUNSCREEN

Sport

Broad Spectrum SPF 50

  • Water Resistant

    (80 minutes)
  • UVA/UVB

    protection

50

10 FL OZ (295 mL)







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

  • May stain some fabrics


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

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 broad spectrum SPF of 15 or higher and other sun protection measures including:

  •  limit time in sun, especially from 10.00 a.m. - 2.00 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)
  • protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 5.0%, Oxybenzone 6.0%

Inactive Ingredients

Water, Neopentyl Glycol Diheptanoate, Styrene/Acrylates Copolymer, Propylene Glycol,Polyglyceryl-3 Methylglucose Distearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer,Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Disodium EDTA, Tocopherol, Oleth-3, Chlorphenesin, Fragrance.

Questions Or Comments? (Questions or Comments?)

Call 1-800-WALGREENS (1-800-925-4733)

Principal Display Panel

NDC 0363-4734-27

BONUS SIZE

Well at Walgreens

25% MORE FREE

WALGREENS PHARMACIST RECOMMENDED*

SUNSCREEN

Sport

Broad Spectrum SPF 50

  • Water Resistant

    (80 minutes)
  • UVA/UVB

    protection

50

10 FL OZ (295 mL)







When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children (Keep out of reach of children)

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

  • May stain some fabrics


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)