Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 65b1a431-bb64-430c-bb6b-4b6b3cb445bf
Route
TOPICAL
Published
Effective Date 2016-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (13 g) Octisalate (5 g) Octocrylene (7 g) Oxybenzone (4 g)
Inactive Ingredients
Water Sorbitol Stearic Acid Trolamine Aluminum Starch Octenylsuccinate Benzyl Alcohol Sorbitan Isostearate Dimethicone Methylparaben Tocopherol Edetate Disodium Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-10-19

Description

Avobenzone 3.0 %, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 7.0%, Oxybenzone 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0 %, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 7.0%, Oxybenzone 4.0%

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 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
  • 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 7.0%, Oxybenzone 4.0%

Inactive Ingredients


Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.



Questions Or Comments?


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



Principal Display Panel

NDC: 0363-4007-19

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED

SUNSCREEN  Lotion

Broad Spectrum SPF 50

  • Water-resistant (80 minutes)
  • UVA/UVB protection

50

8 FL OZ (236 mL)



NDC: 0363-4007-22

BONUS SIZE 25% MORE FREE

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED

SUNSCREEN Lotion

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 a 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 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
  • 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 7.0%, Oxybenzone 4.0%

Inactive Ingredients (Inactive ingredients)


Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.



Questions Or Comments? (Questions or Comments?)


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



Principal Display Panel

NDC: 0363-4007-19

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED

SUNSCREEN  Lotion

Broad Spectrum SPF 50

  • Water-resistant (80 minutes)
  • UVA/UVB protection

50

8 FL OZ (236 mL)



NDC: 0363-4007-22

BONUS SIZE 25% MORE FREE

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED

SUNSCREEN Lotion

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 a Poison Control Center right away.

  • May stain some fabrics


Advanced Ingredient Data


Raw Label Data

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