Label: RIO RADIANCE SPF 50 BODY OIL- octocrylene, homosalate, octisalate, avobenzone oil
- NDC Code(s): 83982-4837-1
- Packager: SOL DE JANEIRO USA, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 27, 2024
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- ACTIVE INGREDIENT
-
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
- DOSAGE & ADMINISTRATION
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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
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RIO RADIANCE SPF 50 BODY OIL
octocrylene, homosalate, octisalate, avobenzone oilProduct 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)