DERMATONE SPORT SPF 50- avobenzone 3%, homosalate 10%, octocrylene 6% lotion

Dermatone Sport SPF 50 by

Drug Labeling and Warnings

Dermatone Sport SPF 50 by is a Otc medication manufactured, distributed, or labeled by Dermatone Labs LLC, Inspec Solutions LLC, Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octocrylene 6.0%

INDICATIONS & USAGE

Uses

Helps prevent sunburn, higher SPF gives more sunburn protection

WARNINGS

WARNINGS

For external use only.

When using this product:

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash occurs.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

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

INACTIVE INGREDIENT

Aluminum Starch Octenylsuccinate
Benzyl Alcohol
Butyloctyl Salicylate
Carbomer
D-Glucitol
Dimethicone
Disodium EDTA
Ethylhexylglycerin
Fragrance
Phenoxyethanol
Polyglyceryl-3-Distearate
Sorbitan Isostearate
Stearic Acid
Triethanolamine
VP/Eicosene Copolymer
Water

DOSAGE & ADMINISTRATION

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

٠For sunscreen use
٠apply to all areas of the skin exposed to the sun.
٠Reapply as needed or after towel drying, swimming, or sweating.

PURPOSE

Sunscreen

DO NOT USE

STOP USE

ASK DOCTOR

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMATONE SPORT SPF 50 
avobenzone 3%, homosalate 10%, octocrylene 6% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54414-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM)	6 g  in 100 mL
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CARBOMER (UNII: 0A5MM307FC)
SORBITOL (UNII: 506T60A25R)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54414-027-11	3784 mL in 1 CONTAINER; Type 0: Not a Combination Product	06/26/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/26/2022

Labeler - Dermatone Labs LLC (100928460)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(54414-027)