OATHOLOGY INZINCABLE LIP BALM SPF 35- zinc oxide ointment

Oathology Inzincable Lip Balm SPF 35 by

Drug Labeling and Warnings

Oathology Inzincable Lip Balm SPF 35 by is a Otc medication manufactured, distributed, or labeled by SKINOATH LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 15.00 %

Purposes

Sunscreen

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

Warnings:

For external use only

Do not use

• on damaged or broken skin.

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

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.

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)

Questions?

(513) 650-OATH

Package Labeling:

INGREDIENTS AND APPEARANCE

OATHOLOGY INZINCABLE LIP BALM SPF 35 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85562-694
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	150 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATERMELON (UNII: 231473QB6R)
ETHYL VANILLIN (UNII: YC9ST449YJ)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL OLEATE (UNII: 4PC054V79P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
OCTYLDODECANOL (UNII: 461N1O614Y)
PETROLATUM (UNII: 4T6H12BN9U)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
D&C RED NO. 30 (UNII: 2S42T2808B)
CASTOR OIL (UNII: D5340Y2I9G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85562-694-00	1 in 1 BOX	04/22/2025
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/22/2025

Labeler - SKINOATH LLC (090820399)

Registrant - Pure Source, LLC (080354456)