Ocean Potion Suncare Mineral 50 Essential Scent Of Sunshine Zinc Oxide Continuous Spray Sunscreen

Ocean Potion Suncare Mineral 50 Essential Scent Of Sunshine Zinc Oxide Continuous Spray Sunscreen
SPL v1
SPL
SPL Set ID 3caaea85-0dfe-6f69-e063-6294a90a7d4a
Route
TOPICAL
Published
Effective Date 2025-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (206 mg)
Inactive Ingredients
Sodium Benzoate Cetostearyl Alcohol Hexamethyldisiloxane Sunflower Oil Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Levomenol Polysorbate 60 Farnesol Phenoxyethanol Olive Oil Polyglyceryl-6 Esters Sodium Stearoyl Lactylate Tetrasodium Glutamate Diacetate Water Isohexadecane Alkyl (c12-15) Benzoate Medium-chain Triglycerides Vinylpyrrolidone/hexadecene Copolymer Sorbitan Isostearate Ethyl Ferulate Triethoxycaprylylsilane Gluconolactone Polysorbate 80 Glyceryl Monostearate .alpha.-tocopherol, Dl- Aloe Vera Leaf Glycerin Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-06

Description

Zinc Oxide 20.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20.6%

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
Labels

Warnings

​For external use only

Directions

• spray liberally and spread evenly by hand 15 minutes before sun exposure

• hold can 4-6 inches away from skin top apply

• do not spray into face. Spray into hand and apply to face.

• use in a well ventilated areas



reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months: 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

Flammable:

• do not use near heat, flame or while smoking



• avoid long term storage above 104°F (40°C)

​do Not Use

  • ​​on damaged or broken skin

Other Information

• protect the product in the container from excessive heat and direct sun

• may stain or damage some fabrics

Active Ingredients

Zinc Oxide 20.6%

Inactive Ingredients

aloe barbadensis leaf juice, bisabolol,

C12-C15 alkyl benzoate, caprylic/capric triglyceride, cetearyl alcohol,

dimethicone, ethyl ferulate, farnesol, fragrance, gluconolactone, glycerin, glyceryl

stearate, helianthus annuus (sunflower) seed oil, hydroxyethyl

acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, olive

oil polyglyceryl-6 esters, phenoxyethanol, polysorbate 60, polysorbate 80,

sodium benzoate, sodium stearoyl lactylate, sorbitan isostearate,

tetrasodium glutamate diacetate, tocopherol, triethoxycaprylylsilane,

VP/hexadecene copolymer, water, xanthan gum

When Using This Product

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

• keep away from to avoid breathing it.

• do not puncture or incinerate. Contents under pressure.

• do not store at temperatures above 120° F.

Stop Use and Ask 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.


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
Labels

Purpose

Sunscreen

Warnings

​For external use only

Directions

• spray liberally and spread evenly by hand 15 minutes before sun exposure

• hold can 4-6 inches away from skin top apply

• do not spray into face. Spray into hand and apply to face.

• use in a well ventilated areas



reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months: 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

Flammable: (FLAMMABLE:)

• do not use near heat, flame or while smoking



• avoid long term storage above 104°F (40°C)

​do Not Use (​Do not use)

  • ​​on damaged or broken skin

Other Information

• protect the product in the container from excessive heat and direct sun

• may stain or damage some fabrics

Active Ingredients (Active ingredients)

Zinc Oxide 20.6%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, bisabolol,

C12-C15 alkyl benzoate, caprylic/capric triglyceride, cetearyl alcohol,

dimethicone, ethyl ferulate, farnesol, fragrance, gluconolactone, glycerin, glyceryl

stearate, helianthus annuus (sunflower) seed oil, hydroxyethyl

acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, olive

oil polyglyceryl-6 esters, phenoxyethanol, polysorbate 60, polysorbate 80,

sodium benzoate, sodium stearoyl lactylate, sorbitan isostearate,

tetrasodium glutamate diacetate, tocopherol, triethoxycaprylylsilane,

VP/hexadecene copolymer, water, xanthan gum

When Using This Product (When using this product)

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

• keep away from to avoid breathing it.

• do not puncture or incinerate. Contents under pressure.

• do not store at temperatures above 120° F.

Stop Use and Ask Doctor If​ (Stop use and ask 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.


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