Active ingredient

Homosalate 14%

Titanium Dioxide 10%

Ethylhexyl Salicylate 4.5%

Phenylbenzimidazole Sulfonic Acid 1.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

lf used as directed with other sunburn 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 to skin liberally, avoiding the eye area.
Wait at least 30 mins before sun exposure, or as directed by a physician.
Re-apply after 80 mniutes of swimming and/or sweating.
Re-apply immediately after towel drying and at least every 3 hours.

Inactive ingredients

Aluminum Hydroxide, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Dimethicone, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, lsohexadecane, Peg-100 Stearate, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Propylene Glycol, Stearic Acid, Triethanolamine, VP Eicosene Copolymer, Water, Xanthan Gum, 1,2 Hexanediol

image of pouch label

MY MEDIC SPF 30 REEF FRIENDLY SUNSCREEN
homosalate, titanium dioxide, ethylhexyl salicylate, phenylbenzimidazole sulfonic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81417-009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	14 g in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-100 STEARATE (UNII: YD01N1999R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
XANTHAN GUM (UNII: TTV12P4NEE)
LEVOMENOL (UNII: 24WE03BX2T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
WATER (UNII: 059QF0KO0R)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81417-009-01	3.5 g in 1 POUCH; Type 0: Not a Combination Product	10/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	10/31/2022