Sunstation Sport Sunscreen Spf 30

Sunstation Sport Sunscreen Spf 30
SPL v1
SPL
SPL Set ID ba78aa73-a25b-4a8e-99b2-9262bb9a7d27
Route
TOPICAL
Published
Effective Date 2025-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ethylhexyl Salicylate (50 mg) Octocrylene (80 mg) Zinc Cation
Inactive Ingredients
Aloe Vera Leaf Butyloctyl Salicylate Calendula Officinalis Flower Carbomer Homopolymer, Unspecified Type Ceteareth-20 Cetearyl Alcohol Chamomile Dimethicone Ethylhexylglycerin Glycerin Glyceryl Stearate Se 1,2-hexanediol Isocetyl Stearate Malva Sylvestris Flower Asian Ginseng Phenoxyethanol Polysorbate 20 Sorbitan Monostearate Sorbitol Stearic Acid .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-19

Description

Octisalate 5% Octocrylene 8% Zinc Oxide 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octisalate 5% Octocrylene 8% Zinc Oxide 8%

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes of swimming or sweating
  • 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.

Do Not Use
  • on damaged or broken skin.

Directions:
  • Apply liberally 15 minutes before sun exposure & as needed.
  • For children under 6 months of age: ask a doctor.
  • 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. -2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Drug Facts:

Package Labeling:

Active Ingredients

Octisalate 5%

Octocrylene 8%

Zinc Oxide 8%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Calendula Officinalis Extract, Capryloyl Glycerin/Sebacic Acid Copolymer, Carbomer,

Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate

SE, 1,2-Hexanediol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol,

Polyhydroxystearic Acid, Polysorbate 20, Sorbitan Stearate, Sorbitol, Stearic Acid, Symphytum Officinale Extract, Tocopheryl Acetate,

Triethanolamine, Water (Aqua)

When Using This Product
  • keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If
  • Rash or irritation develops and lasts.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Uses: (USES:)
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes of swimming or sweating
  • 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: (WARNINGS:)

For external use only.

Do Not Use (Do not use)
  • on damaged or broken skin.

Directions: (DIRECTIONS:)
  • Apply liberally 15 minutes before sun exposure & as needed.
  • For children under 6 months of age: ask a doctor.
  • 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. -2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Drug Facts: (DRUG FACTS:)

Package Labeling:

Active Ingredients

Octisalate 5%

Octocrylene 8%

Zinc Oxide 8%

Other Information: (OTHER INFORMATION:)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Calendula Officinalis Extract, Capryloyl Glycerin/Sebacic Acid Copolymer, Carbomer,

Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate

SE, 1,2-Hexanediol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol,

Polyhydroxystearic Acid, Polysorbate 20, Sorbitan Stearate, Sorbitol, Stearic Acid, Symphytum Officinale Extract, Tocopheryl Acetate,

Triethanolamine, Water (Aqua)

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 or irritation develops and lasts.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.


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