MYDERM SPF 50- homosalate 10.00% octocrylene 6.00% avobenzone 3.00% lotion

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients                 Purpose

Homosalate 10.00%                 Sunscreen              
Octocrylene 6.00%                   Sunscreen
Avobenzone 3.00%                   Sunscreen

PURPOSE

Keep out of reach of children.

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

INDICATIONS & USAGE

Uses

Helps prevent sunburn.

WARNINGS

WARNINGS

For external use only.

When using this product:

Stop use and ask a doctor ifrash occurs.

Inactive Ingredeints

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

DOSAGE & ADMINISTRATION

DIRECTIONS

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours

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

Sun Protection Measures. Spending tme in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a 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 a long-sleeve shirt, pants, hats, and sunglasses.
children under 6 months: Ask a doctor.

Do no use: on damage or broken skin

STOP USE

ASK DOCTOR

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYDERM SPF 50 
homosalate 10.00% octocrylene 6.00% avobenzone 3.00% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-289
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)
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: 72667-289-11	3785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2025

Labeler - Inspec Solutions LLC (081030372)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72667-289)