drug facts

drug facts
SPL v1
SPL
SPL Set ID e5edb531-c88a-4556-869a-c255e67369af
Route
topical
Published
Effective Date 2016-04-04
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 2016-01-07

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 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 months 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

11822-1405-1

RITE AID

RENEWAL

sunscreen

with

Vanishing Zinc

BROAD SPECTRUM

SPF 50

UVA/UVB Protection

Water Resistant (80 minutes)

Dermatologist Tested

Face Nose Ears

50

NET WT.

1 OZ. (28.5 g)



Do Not Use

on damaged or broken skin

Active Ingredients

Octocrylene 4.0%, Zinc Oxide 5.0%

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 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 months of age: Ask a doctor

Other Information (Other information)


  • protect this product from excessive heat and direct sun

Inactive Ingredients (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

11822-1405-1

RITE AID

RENEWAL

sunscreen

with

Vanishing Zinc

BROAD SPECTRUM

SPF 50

UVA/UVB Protection

Water Resistant (80 minutes)

Dermatologist Tested

Face Nose Ears

50

NET WT.

1 OZ. (28.5 g)



Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Octocrylene 4.0%, Zinc Oxide 5.0%

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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