SOL DE JANIERO RIO RADIANCE SPF 50 BODY- zinc oxide lotion

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 Ingredients

Zinc Oxide (20.00%)

Purpose

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

• 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.

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

Aqua (Water, Eau), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius Oleosomes, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Dicaprylyl Carbonate, Diisooctyl Succinate, Dimethicone, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Euterpe Oleracea (Acai) Fruit Oil, Gluconolactone, Glycerin, Hectorite, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Irons Oxides (CI77491), Iron Oxides (CI 77499), Isononyl Isononanoate, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Microcrystalline Cellulose, Niacinamide, Parfum (Fragrance), Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Polysorbate 60, Pongamia Pinnata Seed Extract, Sodium Benzoate, Sodium Stearoyl Glutamate, Sorbitan Isostearate, Sorbitan Oleate, Tetrasodium Glutamate Diacetate, Theobroma Grandiflorum (Cupuacu) Seed Butter, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Triethoxycaprylylsilane, Benzyl Salicylate, Citronellol, Limonene.

Questions or comments?

soldejaneiro.com

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton

SOL
DE
JANEIRO

SUN
CARE

RIO
RADIANCE™
SPF 50 BODY LOTION

Cheirosa 87 Fragrance

100% MINERAL

Illuminating Sunscreen

UVA + UVB Broad Sprectrum SPF 50

6.7 fl oz / 200 mL ℮

INGREDIENTS AND APPEARANCE

SOL DE JANIERO RIO RADIANCE SPF 50 BODY 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-4838
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	Zinc Oxide	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT OIL (UNII: Q9L0O73W7L)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACAI OIL (UNII: Z0W6766A2W)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
HECTORITE (UNII: 08X4KI73EZ)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
NIACINAMIDE (UNII: 25X51I8RD4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
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: 66163-4838-1	1 in 1 CARTON	03/27/2024
1		200 mL in 1 BOTTLE; 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)