Oathology Inzincable Lip Balm Spf 35

Oathology Inzincable Lip Balm Spf 35
SPL v1
SPL
SPL Set ID 289a5492-af57-42e5-82af-3f1e4b369d68
Route
TOPICAL
Published
Effective Date 2025-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (150 mg)
Inactive Ingredients
Aloe Vera Leaf Yellow Wax Butyloctyl Salicylate Green Tea Leaf Medium-chain Triglycerides Watermelon Ethyl Vanillin Glycerin Glyceryl Oleate Sunflower Oil Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Octyldodecanol Petrolatum Punica Granatum Root Bark D&c Red No. 30 Castor Oil Hyaluronate Sodium Tocopherol Tridecyl Salicylate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-22

Description

Zinc Oxide 15.00 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 15.00 %

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

Questions?

(513) 650-OATH

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

Zinc Oxide 15.00 %

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

Aloe Barbadensis Leaf Extract, Beeswax, Butyloctyl Salicylate, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Citrullus Lanatus (Watermelon) Fruit Extract, Ethyl Vanillin, Flavor (Aroma), Glycerin, Glyceryl Oleate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polyisobutene, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Octyldodecanol, Petrolatum, Punica Granatum Extract, Red 30 Lake (CI 73360), Ricinus Communis (Castor) Seed Oil, Sodium Hyaluronate, Stevia Rebaudiana Extract, Tocopherol, Tridecyl Salicylate, 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:
  • 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

Questions?

(513) 650-OATH

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

Zinc Oxide 15.00 %

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

Aloe Barbadensis Leaf Extract, Beeswax, Butyloctyl Salicylate, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Citrullus Lanatus (Watermelon) Fruit Extract, Ethyl Vanillin, Flavor (Aroma), Glycerin, Glyceryl Oleate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polyisobutene, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Octyldodecanol, Petrolatum, Punica Granatum Extract, Red 30 Lake (CI 73360), Ricinus Communis (Castor) Seed Oil, Sodium Hyaluronate, Stevia Rebaudiana Extract, Tocopherol, Tridecyl Salicylate, 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.


Advanced Ingredient Data


Raw Label Data

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