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

Purpose

Sunscreen

Description

Octocrylene 4.0%, Zinc Oxide 5.0%


Medication Information

Warnings

For external use only

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

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
Other Information

protect this product from excessive heat and direct sun

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.

Description

Octocrylene 4.0%, Zinc Oxide 5.0%

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)











Do Not Use

on damaged or broken skin

Active Ingredients

Octocrylene 4.0%, Zinc Oxide 5.0%

Questions Or Comments?

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

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

Warnings

For external use only

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

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
Other Information

protect this product from excessive heat and direct sun

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.

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)











Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients

Octocrylene 4.0%, Zinc Oxide 5.0%

Questions Or Comments? (Questions or comments?)

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

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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