FDA.reportPublic FDA data

MD Glam SPF 50

Manufacturer
Spa de Soleil
Effective date
2022-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:44:36

Label at a glance#

ProductMD Glam SPF 50
Active ingredientZINC OXIDE, OCTINOXATE
Label structure7 sections

Dosage and administration

Directions Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Zinc oxide 9.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

Warnings

  • For external use only
  • Do not use on damaged or broken skin

When using this product

  • keep out of the eye area
  • rinse with water to remove
  • stop use and ask a doctor if rash or irritation develops
  • for external use onlyl
  • keep out of reach of children

Jar is glass and may shatter if dropped

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Directions

INDICATIONS & USAGE SECTION

Directions

Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

aqua, cocos nucifera (coconut) oil, carthamus tinctoris (safflower) seed oil, heptyl undecylenate, caprylic/capric triglyceride, cetyl alcohol, glycerin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MD GLAM SPF50 FINAL BOX 2 printOUT.jpgMD GLAM SPF50 FINAL BOX 2 printOUT.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68062-9000-12025-06-02C16284748780-12cef2736-b1eb-d83d-e063-dadaa90ab31fMD Glam SPF 50
68062-9000-12025-01-30C16284748780-12cef2736-b1eb-d83d-e063-dadaa90ab31fMD Glam SPF 50

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68062-9000MD GLAM SPF 50 (OCTINOXATE) LOTION [SPA DE SOLEIL]2Legacy NDC20221217_efd53834-7fb6-818b-e053-2995a90a99d3.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68062-900068062-9000-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEPTYL UNDECYLENATEW77QUB6GXOIACT
ZINC OXIDESOI2LOH54ZACTIB
SAFFLOWER SEED8FCL6A31TXIACT
CAPRYLIC/CAPRIC ACIDDI775RT244IACT
WATER059QF0KO0RIACT
COCONUT OILQ9L0O73W7LIACT
OCTINOXATE4Y5P7MUD51ACTIB

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
50b672e0-d165-cd1d-e063-6394a90a76baefd53834-7fb6-818b-e053-2995a90a99d32026-04-30WarningsExact identifier
spl set id: efd53834-7fb6-818b-e053-2995a90a99d3

Reported adverse events (FAERS/openFDA)#

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