Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c71f4460-a316-428b-9a87-50c41065bc5b
Route
TOPICAL
Published
Effective Date 2016-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (4 g) Zinc Cation (5 g)
Inactive Ingredients
Water Ethylhexyl Stearate Diisopropyl Adipate Polyglyceryl-4 Isostearate Hexyl Laurate Yellow Wax Isohexadecane Sodium Chloride Hydrogenated Castor Oil Silicon Dioxide Triethoxycaprylylsilane Dimethicone Tocopherol Edetate Disodium Aloe Vera Leaf Sodium Ascorbyl Phosphate Phenoxyethanol Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-01-06

Description

Octocrylene 4.0%, Zinc Oxide 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octocrylene 4.0%, Zinc Oxide 5.0%

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 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 month 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

Octocrylene 4.0%, Zinc Oxide 5.0%

Inactive Ingredients

Water, Ethylhexyl Stearate, Diisopropyl Adipate, Cetyl Dimethicone, Polyglyceryl-4

Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Beeswax, Isohexadecane,

Sodium Chloride, Hydrogenated Castor Oil, Silica, Triethoxycaprylylsilane, Dimethicone,

Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl

Phosphate, Phenoxyethanol, Methylparaben, Propylparaben.

Questions Or Comments?

Call 1-800-WALGREENS (1-800-926-4733)

Principal Display Panel

0363-4735-22

NEW Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED

SUNSCREEN

CLEAR ZINC

Broad Spectrum

SPF 50

  • Water-resistant
  • UVA/UVB protection
  • Goes on Clear
  • Non-greasy
  • Dermatologist tested

50

4 FL OZ (118 mL)



0363-4735-23

BONUS SIZE

25% MORE FREE

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED*

SUNSCREEN

Clear Zinc

Broad Spectrum

SPF 50





  • Water-resistant (80 minutes)
  • UVA/UVB protection
  • Goes on clear
  • Non-greasy
  • Dermatologist tested

50

5 FL OZ (147 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 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 month of age: Ask a doctor
Do Not Use (Do not use)

on damaged or broken skin

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Octocrylene 4.0%, Zinc Oxide 5.0%

Inactive Ingredients

Water, Ethylhexyl Stearate, Diisopropyl Adipate, Cetyl Dimethicone, Polyglyceryl-4

Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Beeswax, Isohexadecane,

Sodium Chloride, Hydrogenated Castor Oil, Silica, Triethoxycaprylylsilane, Dimethicone,

Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl

Phosphate, Phenoxyethanol, Methylparaben, Propylparaben.

Questions Or Comments? (Questions or comments?)

Call 1-800-WALGREENS (1-800-926-4733)

Principal Display Panel

0363-4735-22

NEW Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED

SUNSCREEN

CLEAR ZINC

Broad Spectrum

SPF 50

  • Water-resistant
  • UVA/UVB protection
  • Goes on Clear
  • Non-greasy
  • Dermatologist tested

50

4 FL OZ (118 mL)



0363-4735-23

BONUS SIZE

25% MORE FREE

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED*

SUNSCREEN

Clear Zinc

Broad Spectrum

SPF 50





  • Water-resistant (80 minutes)
  • UVA/UVB protection
  • Goes on clear
  • Non-greasy
  • Dermatologist tested

50

5 FL OZ (147 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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