oathology inzincable sunscreen spf 50

oathology inzincable sunscreen spf 50
SPL v1
SPL
SPL Set ID d245dfca-9e32-4e71-9df8-58fff84ef6a9
Route
topical
Published
Effective Date 2025-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (100 mg) octocrylene (50 mg) zinc cation
Inactive Ingredients
acetic acid acetyl hexapeptide-8 amide allantoin aloe vera leaf azelaic acid butyloctyl salicylate caprylyl glycol caprylyl trisiloxane citric acid monohydrate watermelon cyclomethicone 5 glycerin glyceryl laurate glyceryl stearate se isohexadecane niacinamide pentylene glycol phenoxyethanol polysorbate 20 polysorbate 60 potassium sorbate sorbitan isostearate sorbitan sesquioleate .alpha.-tocopherol acetate tribehenin peg-20 esters water ginger oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-04

Purpose

Sunscreen

Description

Homosalate 10.00 % Octocrylene 10.00 % Zinc Oxide 5.00 %


Medication Information

Purpose

Sunscreen

Description

Homosalate 10.00 % Octocrylene 10.00 % Zinc Oxide 5.00 %

Questions?

(513) 650-OATH

Uses:
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • 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
Purposes

Sunscreen

Warnings:

For external use only

Do Not Use
  • on damaged or broken skin.
Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Package Labeling:

Active Ingredients

Homosalate 10.00 %

Octocrylene 10.00 %

Zinc Oxide 5.00 %

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

Acetic Acid, Acetyl Hexapeptide-8, Allantoin, Aloe Barbadensis Leaf Juice, Azelaic Acid, Butyloctyl Salicylate, Caprylyl Glycol, Caprylyl Methicone, Citric Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Cyclopentasiloxane, Glycerin, Glyceryl Laurate, Glyceryl Stearate SE, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Niacinamide, PEG-10 Dimethicone, Pentylene Glycol, Phenoxyethanol, Polysorbate 20, Polysorbate 60, Polyhydroxystearic Acid, Potassium Sorbate, Sodium Polyacrylate, Sorbitan Isostearate, Sorbitan Sesquioleate, Tocopheryl Acetate, Tribehenin PEG-20 Esters, Water (Aqua), Zingiber Officinale (Ginger) Root Oil.

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.
Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding, 

ask a health professional before use


Structured Label Content

Questions?

(513) 650-OATH

Uses:
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • 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
Purposes

Sunscreen

Warnings:

For external use only

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

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Package Labeling:

Active Ingredients

Homosalate 10.00 %

Octocrylene 10.00 %

Zinc Oxide 5.00 %

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

Acetic Acid, Acetyl Hexapeptide-8, Allantoin, Aloe Barbadensis Leaf Juice, Azelaic Acid, Butyloctyl Salicylate, Caprylyl Glycol, Caprylyl Methicone, Citric Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Cyclopentasiloxane, Glycerin, Glyceryl Laurate, Glyceryl Stearate SE, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Niacinamide, PEG-10 Dimethicone, Pentylene Glycol, Phenoxyethanol, Polysorbate 20, Polysorbate 60, Polyhydroxystearic Acid, Potassium Sorbate, Sodium Polyacrylate, Sorbitan Isostearate, Sorbitan Sesquioleate, Tocopheryl Acetate, Tribehenin PEG-20 Esters, Water (Aqua), Zingiber Officinale (Ginger) Root Oil.

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.
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.

If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

ask a health professional before use


Advanced Ingredient Data


Raw Label Data

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