RIO RADIANCE SPF 50 BODY OIL- octocrylene, homosalate, octisalate, avobenzone oil

Rio Radiance SPF 50 Body Oil by

Drug Labeling and Warnings

Rio Radiance SPF 50 Body Oil by is a Otc medication manufactured, distributed, or labeled by SOL DE JANEIRO USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients Purpose

Avobenzone (3.00%)....Sunscreen

Homosalate (7.34%).....Sunscreen

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

Octocrylene (10.00%)..Sunscreen

WARNINGS

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.

QUESTIONS

Questions or comments?
soldejaneiro.com

DOSAGE & ADMINISTRATION

Dosage: Evenly and generously apply to skin.

Administration: Topical

INACTIVE INGREDIENT

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

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PURPOSE

Sunscreen

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RIO RADIANCE SPF 50 BODY OIL 
octocrylene, homosalate, octisalate, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83982-4837
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	77.4 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SAFFLOWER OIL (UNII: 65UEH262IS)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
OENOCARPUS BATAUA FRUIT OIL (UNII: VU97MXB4Z2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
KARUM SEED OIL (UNII: 62160PU6FJ)
MICA (UNII: V8A1AW0880)
STANNOUS OXIDE (UNII: JB2MV9I3LS)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83982-4837-1	1 in 1 CARTON	03/27/2024
1		90 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/27/2024

Labeler - SOL DE JANEIRO USA, INC. (080098027)