SOL DE JANIERO RIO RADIANCE SPF 50 BODY- avobenzone, homosalate, octisalate, and octocrylene oil

Sol de Janiero Rio Radiance SPF 50 Body by

Drug Labeling and Warnings

Sol de Janiero Rio Radiance SPF 50 Body by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone(3.00%)	Sunscreen
Homosalate(7.34%)	Sunscreen
Octisalate(5.00%)	Sunscreen
Octocrylene(10.00%)	Sunscreen

Uses

• Helps prevent sunburn.

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.

Directions

• Shake well before use.
• 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.

SPL UNCLASSIFIED SECTION

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.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

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.

Questions or comments?

soldejaneiro.com

PRINCIPAL DISPLAY PANEL - 90 mL Cylinder Carton

SOL
DE
JANEIRO

SUN CARE

RIO
RADIANCE™

SPF 50 BODY OIL

Cheirosa 87 Fragrance

Shimmering
Sunscreen

UVA + UVB

Broad Spectrum SPF 50

3 fl oz / 90 mL ℮

INGREDIENTS AND APPEARANCE

SOL DE JANIERO RIO RADIANCE SPF 50 BODY 
avobenzone, homosalate, octisalate, and octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-4837
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SAFFLOWER OIL (UNII: 65UEH262IS)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISODODECANE (UNII: A8289P68Y2)
MICA (UNII: V8A1AW0880)
OENOCARPUS BATAUA FRUIT OIL (UNII: VU97MXB4Z2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
KARUM SEED OIL (UNII: 62160PU6FJ)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-4837-1	1 in 1 CARTON	03/27/2024
1		90 mL in 1 CYLINDER; 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 - Cosmetic Solutions LLC (807907928)