FDA.reportPublic FDA data

Rejuvaderm Medispa sunscreen

Manufacturer
Ellen H Frankle MD Inc
Effective date
2010-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:36

Label at a glance#

ProductRejuvaderm Medispa sunscreen
Active ingredientOctinoxate, Octisalate, Zinc Oxide
Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients        Purpose

Octinoxate 7.5%            Sunscreen

Octisalate 2%                 Sunscreen

Zinc Oxide 7.5%            Sunscreen

INDICATIONS & USAGE SECTION


Uses

  • Helps prevent sunburn caused by UVA/UVB exposure
  • Provides high UVB protection

WARNINGS SECTION

Warnings

For external use only

  • UV exposure from the sun increases the risk of skin cance, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.
  • Stop use and ask a doctor if skin rash occurs.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply at least every 2 hours and after towel drying, swimming, or perspiring
  • Children under 6 months of age: ask a doctor
  • Reapply to dry skin as needed or after towel drying, swimming or sweating.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water USP, Isopropyl Myristate, Octyldoceyl Neopentanoate, Caprylic/Capric Triglyceride, Cetearyl alcohol, Polysorbate 60, Diethanolamine Cetyl Phosphate, Hyaluroic Acid, Polyether-1, Galactoarabinan, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Triethoxycaprlylsilane,Sodium Hydroxide, Citric Acid, Phenoxyethanol, Methylparaben, Propylparaben, Disodium EDTA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label
label

Rejuvaderm Medispa

Reawaken the essence that is you

Sunscreen Lotion SPF 40

4 fl oz (120 ml)

401.944skin

www.riskindoc.com

ww.rejuvadermmedispa.com

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51325-100-012019-10-21C16284748780-1956f9ecf-cadd-621f-e053-dbdaa90a74adRejuvaderm Medispa Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51325-100-01Rejuvaderm Medispa sunscreen120 mL in 1 TUBELOTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51325-100REJUVADERM MEDISPA SUNSCREEN (OCTINOXATE, OCTISALATE, ZINC OXIDE) LOTION [ELLEN H FRANKLE MD INC]1Legacy NDC, 1 package rows20100825_1cf73889-aa5f-4a87-8584-348d6192dc24.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51325-10051325-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Octisalate4X49Y0596WACTIB
Zinc OxideSOI2LOH54ZACTIB

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
2cd3a7e4-1a01-465c-a413-6097091030871cf73889-aa5f-4a87-8584-348d6192dc242010-08-18WarningsExact identifier
spl id: 2cd3a7e4-1a01-465c-a413-609709103087
spl set id: 1cf73889-aa5f-4a87-8584-348d6192dc24

Reported adverse events (FAERS/openFDA)#

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