RIO RADIANCE SPF 50 BODYSPRAY- octocrylene, octisalate, avobenzone aerosol, spray

Rio Radiance SPF 50 BodySpray by

Drug Labeling and Warnings

Rio Radiance SPF 50 BodySpray 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

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

Octocrylene (9.00%).......Sunscreen

DOSAGE & ADMINISTRATION

Dosage: Evenly and generously apply to skin.

Administration: Topical

WARNINGS

Warnings:
For external use only.
Do not use on damaged or broken skin.
When using this product keep out 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.

Flammable. Contents under pressure. Do not use near heat or flame.

Do not puncture or incinerate. Do not store at temperatures above 120°F.

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.

INACTIVE INGREDIENT

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Bisabolol, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Cocos Nucifera (Coconut) Water, Diheptyl Succinate, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Eugenia Uniflora Fruit Extract, Leuconostoc/Radish Root Ferment Filtrate, Niacinamide, Parfum (Fragrance), Polyester-8, Pongamia Pinnata Seed Extract, Potassium Sorbate, Sodium Benzoate, 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 BODYSPRAY 
octocrylene, octisalate, avobenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83982-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EUGENIA UNIFLORA FRUIT (UNII: 39OSC52QCD)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALCOHOL (UNII: 3K9958V90M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)
ETHYL FERULATE (UNII: 5B8915UELW)
NIACINAMIDE (UNII: 25X51I8RD4)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
COCONUT WATER (UNII: 267F5Y81NT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83982-1001-1	1 in 1 CARTON	03/27/2024
1		200 mL in 1 CANISTER; 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)