FDA.reportPublic FDA data

MY MEDIC SPF 30 REEF FRIENDLY SUNSCREEN

Manufacturer
Sled Distribution, LLC
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:19

Label at a glance#

ProductMY MEDIC SPF 30 REEF FRIENDLY SUNSCREEN
Active ingredientENSULIZOLE, OCTISALATE, HOMOSALATE, TITANIUM DIOXIDE
Label structure7 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Homosalate 14%

Titanium Dioxide 10%

Ethylhexyl Salicylate 4.5%

Phenylbenzimidazole Sulfonic Acid 1.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - WHEN USING SECTION

  • When using this product keep out of eyes.

Rinse with water to remove.

OTC - ASK DOCTOR SECTION

  • Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of pouch labelimage of pouch label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81417-009-01MY MEDIC SPF 30 REEF FRIENDLY SUNSCREEN3.5 g in 1 POUCHCREAM3.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81417-009MY MEDIC SPF 30 REEF FRIENDLY SUNSCREEN (HOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACID) CREAM [SLED DISTRIBUTION, LLC]2Current NDC, Legacy NDC, 1 package rows20240116_ec252876-7205-83ec-e053-2a95a90a1463.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81417-00981417-009-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-100 STEARATEYD01N1999RIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
XANTHAN GUMTTV12P4NEEIACT
LEVOMENOL24WE03BX2TIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
WATER059QF0KO0RIACT
ENSULIZOLE9YQ9DI1W42ACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
STEARIC ACID4ELV7Z65APIACT
ISOHEXADECANE918X1OUF1EIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MY MEDIC SPF 30 REEF FRIENDLY SUNSCREENHOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACIDSled Distribution, LLCec252876-7205-83ec-e053-2a95a90a14632024-01-15WarningsExact identifier
ndc (package): 81417-009-01
ndc (product): 81417-009
ndc11 (package): 81417000901
spl id: 0eff83bb-ba02-3c1d-e063-6294a90a7b4f
spl set id: ec252876-7205-83ec-e053-2a95a90a1463

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.