OATHOLOGY INZINCABLE SUNSCREEN SPF 50- homosalate, octocrylene, zinc oxide lotion

Oathology Inzincable Sunscreen SPF 50 by

Drug Labeling and Warnings

Oathology Inzincable Sunscreen SPF 50 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

Homosalate 10.00 %
Octocrylene 10.00 %
Zinc Oxide 5.00 %

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:

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.

Questions?

(513) 650-OATH

Package Labeling:

INGREDIENTS AND APPEARANCE

OATHOLOGY INZINCABLE SUNSCREEN SPF 50 
homosalate, octocrylene, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85562-594
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACETIC ACID (UNII: Q40Q9N063P)
ACETYL HEXAPEPTIDE-8 AMIDE (UNII: L4EL31FWIL)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AZELAIC ACID (UNII: F2VW3D43YT)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATERMELON (UNII: 231473QB6R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ISOHEXADECANE (UNII: 918X1OUF1E)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
WATER (UNII: 059QF0KO0R)
GINGER OIL (UNII: SAS9Z1SVUK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85562-594-00	1 in 1 BOX	03/04/2025
1		100 mL in 1 BOTTLE; 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	03/04/2025

Labeler - SKINOATH LLC (090820399)

Registrant - Pure Source, LLC (080354456)