POTH CLEAR GEL SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene gel

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 10%

Purpose

Sunscreen

Uses

• Help prevent sunburn.
• 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 occurs

Keep out of reach of children.

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

Directions

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months: 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 the risk, regularly use a sunscreen with broad spectrum of 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 this product from high heat and direct sun.

Inactive Ingredients

Ascorbic Acid, Beeswax, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Ethyl Vanillin, Isododecane, Jojoba Esters, Lecithin, Meadowfoam Estolide, Microcrystalline Wax, Polyhydroxystearic Acid, Silica, Tocopherol, Tridecyl Salicylate, Zinc Sulfate

Questions?

1-201-677-8827 or www.pothskin.com/spf

Package Labeling:

INGREDIENTS AND APPEARANCE

POTH CLEAR GEL SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87669-963
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BEESWAX (UNII: 2ZA36H0S2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
ETHYL VANILLIN (UNII: YC9ST449YJ)
ISODODECANE (UNII: A8289P68Y2)
MEADOWFOAM ESTOLIDE (UNII: 3HH93SL2H9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ZINC SULFATE (UNII: 89DS0H96TB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87669-963-00	1 in 1 BOX	04/14/2024
1		59 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	04/14/2024

Labeler - Poth LLC (144989013)

Registrant - Pure Source, LLC (080354456)