Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c2d57a44-ea49-44ac-be36-09b230bfb75c
Route
TOPICAL
Published
Effective Date 2016-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (15 g) Octisalate (5 g) Octocrylene (10 g) Oxybenzone (6 g)
Inactive Ingredients
Water Glyceryl Monostearate Cellulose, Microcrystalline Butylene Glycol Peg-100 Stearate Benzyl Alcohol Diethylhexyl Syringylidenemalonate Docosanol Palmitic Acid Stearic Acid Carboxymethylcellulose Sodium, Unspecified Form Medium-chain Triglycerides Cetyl Alcohol Lauryl Alcohol Myristyl Alcohol Vitamin A Palmitate Edetate Disodium Sodium Ascorbyl Phosphate Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-09

Description

Avobenzone 3.0%,Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%,Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, 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 a broad spectrum SPF of 15 or higher and other protection measures including:

•    limit time in the sun, especially from 10 a.m. to 2 p.m.

•    wear long-sleeved shirts, pants, hats, and sunglasses

•    children under 6 months: 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 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

Inactive Ingredients

Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Acrylates/C12-22 Alkyl ethacrylate Copolymer, Butylated PVP, Palmitic Acid, Stearic Acid, Cellulose Gum, Caprylic/Capric Triglyceride, Cetyl Alcohol, Lauryl Alcohol, Lecithin, Myristyl Alcohol, Retinyl Palmitate, ocopherol, Disodium EDTA, Sodium Ascorbyl Phosphate, Chlorphenesin.

Questions Or Comments?

1-800-WALGREENS (1-800-925-4133)

Principle Display Label

NDC:  0363-1671-26

NEW

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED*

SUNSCREEN

Sport

Broad Spectrum SPF 70

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

70

8 FL OZ (236 mL)



NDC:  0363-1671-27

BONUS SIZE

Well at Walgreens

20% MORE FREE

WALGREENS PHARMACIST RECOMMENDED*

NEW

SUNSCREEN

Sport

Broad Spectrum SPF 70

  • Water Resistant (80 minutes)
  • UVA/UVB Protection

70

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 of 15 or higher and other protection measures including:

•    limit time in the sun, especially from 10 a.m. to 2 p.m.

•    wear long-sleeved shirts, pants, hats, and sunglasses

•    children under 6 months: 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 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

Inactive Ingredients (Inactive ingredients)

Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Acrylates/C12-22 Alkyl ethacrylate Copolymer, Butylated PVP, Palmitic Acid, Stearic Acid, Cellulose Gum, Caprylic/Capric Triglyceride, Cetyl Alcohol, Lauryl Alcohol, Lecithin, Myristyl Alcohol, Retinyl Palmitate, ocopherol, Disodium EDTA, Sodium Ascorbyl Phosphate, Chlorphenesin.

Questions Or Comments? (Questions or comments?)

1-800-WALGREENS (1-800-925-4133)

Principle Display Label

NDC:  0363-1671-26

NEW

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED*

SUNSCREEN

Sport

Broad Spectrum SPF 70

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

70

8 FL OZ (236 mL)



NDC:  0363-1671-27

BONUS SIZE

Well at Walgreens

20% MORE FREE

WALGREENS PHARMACIST RECOMMENDED*

NEW

SUNSCREEN

Sport

Broad Spectrum SPF 70

  • Water Resistant (80 minutes)
  • UVA/UVB Protection

70

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

All Sections (JSON)