SPF 55 SUNSCREEN CANISUN- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion

SPF 55 Sunscreen by

Drug Labeling and Warnings

SPF 55 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children.

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

Directions

Apply liberally 15 minutes before sun exposure. Reapply:

• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

• limit time in the sun, especially from 10 am to 2 pm
• wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months: ask a doctor.

Inactive Ingredients

1,2 Hexanediol, Acetyl Glucosamine, Behenyl Alcohol, Beta-Glucan, BHT, Butyloctyl Salicylate, Cannabidiol, Caprylyl Methicone, Diethylhexyl 2,6-Naphthalate, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Stearate, Glycolic Acid, Hydrated Silica, Hydrogenated Lecithin, Levan (Fructan), Musa Sapientum (Banana) Fruit Extract, PEG-100 Stearate, Phenoxyethanol, Sodium Hyaluronate, Sodium Polyacrylate, Sodium Polyglutamate, Squalane, Styrene/Acrylates Copolymer, Trideceth-6, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water, Xanthan Gum.

Label

INGREDIENTS AND APPEARANCE

SPF 55 SUNSCREEN  CANISUN
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CANNABIDIOL (UNII: 19GBJ60SN5)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG-100 STEARATE (UNII: YD01N1999R)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MONOSODIUM DL-GLUTAMATE (UNII: LX3YQ006AP)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
GLYCOLIC ACID (UNII: 0WT12SX38S)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
DOCOSANOL (UNII: 9G1OE216XY)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
BANANA (UNII: 4AJZ4765R9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SQUALANE (UNII: GW89575KF9)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CURDLAN (UNII: 6930DL209R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-027-03	89 mL in 1 TUBE; Type 0: Not a Combination Product	06/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/14/2019

Labeler - Derma Care Research Labs, LLC (116817470)