FDA.reportPublic FDA data

Rio Radiance SPF 50 Body Oil

Manufacturer
SOL DE JANEIRO USA, INC.
Effective date
2024-03-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:23

Label at a glance#

ProductRio Radiance SPF 50 Body Oil
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients Purpose

Avobenzone (3.00%)....Sunscreen

Homosalate (7.34%).....Sunscreen

Octisalate (5.00%)........Sunscreen

Octocrylene (10.00%)..Sunscreen

WARNINGS SECTION

Warnings:

• For extemal use only.
• Do not use on damaged or broken skin.
• When using this product keep our 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.

Sun Protection Measures: Spending time in the sun increases

your risk of skin cancer and early skin aging. To decrease this risk,

regularly use a sunscreen with a Broad Spectrum SPF value of 15 or

higher and other sun protection measures including:

• Limit time in the sun, especially from 10am - 2pm.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

OTC - QUESTIONS SECTION

Questions or comments?
soldejaneiro.com

DOSAGE & ADMINISTRATION SECTION

Dosage: Evenly and generously apply to skin.

Administration: Topical

INACTIVE INGREDIENT SECTION

Butyloctyl Salicylate, Carthamus Tinctorius Seed Oil, Diethylhexyl 2,6-Naphthalate, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Iron Oxides (CI 77491), Isododecane, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Oenocarpus Bataua Fruit Oil, Parfum (Fragrance), Phenoxyethanol, Pongamia Glabra Seed Oil, Pongamia Pinnata Seed Extract, Synthetic Fluorphlogopite, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Tocopheryl Acetate, Benzyl Salicylate, Citronellol, Limonene.

INDICATIONS & USAGE SECTION

Uses:

• Helps prevent sunburn.

Directions:

• Apply generously and evenly 15 minutes before sun exposure.
• Children under 6 months of age: ask a doctor.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rio Radiance SPF 50 Body Oil_TubeRio Radiance SPF 50 Body Oil_TubeRio Radiance SPF 50 Body Oil_CartonRio Radiance SPF 50 Body Oil_Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83982-4837-1Rio Radiance SPF 50 Body Oil90 mL in 1 TUBEOIL901
83982-4837-1Rio Radiance SPF 50 Body Oil1 in 1 CARTONOIL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83982-4837RIO RADIANCE SPF 50 BODY OIL (OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE) OIL [SOL DE JANEIRO USA, INC.]1Current NDC, 2 package rows20240330_14acf152-e72a-debb-e063-6294a90a243d.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83982-483783982-4837-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SAFFLOWER OIL65UEH262ISIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
ISODODECANEA8289P68Y2IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
OCTISALATE4X49Y0596WACTIB
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
OENOCARPUS BATAUA FRUIT OILVU97MXB4Z2IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
PHENOXYETHANOLHIE492ZZ3TIACT
AVOBENZONEG63QQF2NOXACTIB
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
KARUM SEED OIL62160PU6FJIACT
MICAV8A1AW0880IACT
STANNOUS OXIDEJB2MV9I3LSIACT
TOCOPHEROLR0ZB2556P8IACT

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
Rio Radiance SPF 50 Body OilOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONESOL DE JANEIRO USA, INC.14acf152-e72a-debb-e063-6294a90a243d2024-03-27WarningsExact identifier
ndc (package): 83982-4837-1
ndc (product): 83982-4837
ndc11 (package): 83982483701
spl id: 14acf152-e72b-debb-e063-6294a90a243d
spl set id: 14acf152-e72a-debb-e063-6294a90a243d

Reported adverse events (FAERS/openFDA)#

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