FDA.reportPublic FDA data

Rejuvaderm Medispa Body

Manufacturer
Ellen H Frankle MD Inc
Effective date
2010-08-03
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 Body
Active ingredientOctinoxate, Octisalate, Oxybenzone
Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Active Ingredients     Purpose

Octinoxate 7.5%          Sunscreen

Octisalate 5.0%           Sunscreen

Oxybenzone 3.0%      Sunscreen

INDICATIONS & USAGE SECTION


Uses

Helps prevent sunburn.

Higher SPF gives more sunburn protection.

Provides moderate protection against sunburn.

WARNINGS SECTION


Warnings

For external use only

When using this product

  • keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if
  • rash or irritation develops and lasts.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION


Inactive Ingredients Water (Aqua), Glycolic Acid, C12-15 Alkyl Benzoate, Cyclomethicone, Glyceryl Stearate, Glycerin, Ammonium Hydroxide, PEG-150  Stearate, Polyacrylamide, Cetyl alcohol, Cetearyl Alcohol, Butyrospermum Parkii (shea butter), Cholesterol, Phenozyethanol,Dimethiconol, C13-14 Isoparaffin, Methylparaben, Xanathan gum, cetearyl glucoside, Disodium EDTA, Tocopheryl acetate, Laureth-7

DOSAGE & ADMINISTRATION SECTION


Directions:

  • Apply daily to cleansed body skin or as directed by your physician; avoid face.
  • Apply generously before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
Other Information
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and harmful effects of the sun.
This product is not intended for sunbathing.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51325-200-022019-10-21C16284748780-1956f9ecf-bc07-621f-e053-dbdaa90a74adRejuvaderm Medispa Body

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51325-200-02Rejuvaderm Medispa Body355 mL in 1 BOTTLELOTION3551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51325-200REJUVADERM MEDISPA BODY (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [ELLEN H FRANKLE MD INC]1Legacy NDC, 1 package rows20100825_4e666f5c-5c3e-41b4-ba33-632c78217b4e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1

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
51325-20051325-200-02

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
Oxybenzone95OOS7VE0YACTIB

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
656a38b5-c598-4e10-995e-4bdbd5057e124e666f5c-5c3e-41b4-ba33-632c78217b4e2010-08-03WarningsExact identifier
spl id: 656a38b5-c598-4e10-995e-4bdbd5057e12
spl set id: 4e666f5c-5c3e-41b4-ba33-632c78217b4e

Reported adverse events (FAERS/openFDA)#

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