RIO RADIANCE SPF 50 BODYLOTION- zinc oxide lotion

Rio Radiance SPF 50 BodyLotion by

Drug Labeling and Warnings

Rio Radiance SPF 50 BodyLotion 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

Zinc Oxide (20.00%)......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.

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

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 (Açaí) Fruit Oil, Gluconolactone, Glycerin, Hectorite, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Iron Oxides (CI 77491), 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 (Cupuaçu) Seed Butter, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Triethoxycaprylylsilane, 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 BODYLOTION 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83982-4838
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
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERIN (UNII: PDC6A3C0OX)
COCO GLUCOSIDE (UNII: ICS790225B)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
HECTORITE (UNII: 08X4KI73EZ)
SAFFLOWER OIL (UNII: 65UEH262IS)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STANNIC OXIDE (UNII: KM7N50LOS6)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
COCONUT OIL (UNII: Q9L0O73W7L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ACAI OIL (UNII: Z0W6766A2W)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83982-4838-0	1 in 1 CARTON	03/27/2024
1		240 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)