Ocean Potion Face With Clear Zinc Oxide Broad Spectrum Spf 50 Sunscreen

Ocean Potion Face With Clear Zinc Oxide Broad Spectrum Spf 50 Sunscreen
SPL v1
SPL
SPL Set ID 3c6f3e0b-2dff-6dc3-e063-6394a90abb0e
Route
TOPICAL
Published
Effective Date 2024-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (50.2125 mg) Octocrylene (40 mg)
Inactive Ingredients
Polyglyceryl-4 Isostearate Sodium Chloride Edetic Acid Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Triethoxycaprylylsilane Hexyl Laurate Ethylhexyl Stearate Cetyl Dimethicone 25 Sodium Ascorbyl Phosphate Aloe Vera Leaf Silicon Dioxide Yellow Wax Hydrogenated Castor Oil Isohexadecane Diisopropyl Adipate Water Phenoxyethanol Dimethicone Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-17

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 aging caused by the sun
Label

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
  • children under 6 months of age: Ask a doctor
  • 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
Do Not Use

on damaged or broken skin.

Other Information
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
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, phenoxyethanol, beeswax, isohexadecane, hydrogenated castor oil, fragrance, silica, triethoxycaprylylsilane, dimethicone, tocopherol (Vitamin E), tetrasodium EDTA, aloe barbadensis leaf juice, sodium chloride, sodium ascorbyl phosphate.

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 swallowed, get medical help or contact a Poison Control Center right away.


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 aging caused by the sun
Label

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
  • children under 6 months of age: Ask a doctor
  • 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
Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients (Active ingredients)

Octocrylene 4.0%, Zinc Oxide 5.0%

Inactive Ingredients (Inactive ingredients)

water, ethylhexyl stearate, diisopropyl adipate, cetyl dimethicone, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, phenoxyethanol, beeswax, isohexadecane, hydrogenated castor oil, fragrance, silica, triethoxycaprylylsilane, dimethicone, tocopherol (Vitamin E), tetrasodium EDTA, aloe barbadensis leaf juice, sodium chloride, sodium ascorbyl phosphate.

When Using This Product (When using this product)

​• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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