SOLEIL SUPERIEUR BODY SPF 50 US- avobenzone, homosalate, octisalate, octocrylene cream 
RV Skincare LLC

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Soleil Superieur Body SPF 50 US

Drug Facts

Active ingredients

Avobenzone 3.00%

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 2.60%

Purpose

Sunscreen

Uses

• helps prevent sunburn

• if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• For sunscreen use: • apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • 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 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: Ask a doctor






Sun Protection Measures.

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

Aqua (Water, Eau), Ethylhexyl Salicylate, Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Potassium Cetyl Phosphate, PEG-100 Stearate, Glyceryl Stearate, Methyl Glucose Sesquistearate, Alcohol Denat., Oligopeptide-24, Tocopheryl Acetate, Caprylyl Glycol, Polyacrylate-15, PEG-10 Dimethicone,  Carnosine, Lecithin, Polyacrylate-17, Silybin, Tocopherol, Glycerin, Sodium Oleate, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Hexylene Glycol, C11-15 Pareth-7, C11-15 Pareth-40, Parfum (Fragrance), Sodium Laureth-12 Sulfate, Disodium Lauryl Sulfosuccinate, Hydrogenated Palm Glycerides, Cetyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Disodium EDTA, Potassium Sorbate,  Potassium Hydroxide, Citric Acid. 

Questions or comments?

Call , M – F 8am – 5pm CST. 1-866-986-7083

Package Labeling:

Outer Package06Inner Package06Box4

SOLEIL SUPERIEUR BODY SPF 50 US 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82691-145
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE26 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
ALCOHOL (UNII: 3K9958V90M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARNOSINE (UNII: 8HO6PVN24W)  
SILIBININ (UNII: 4RKY41TBTF)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM OLEATE (UNII: 399SL044HN)  
SOYBEAN OIL (UNII: 241ATL177A)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
C11-15 PARETH-7 (UNII: 261HPE0IS3)  
C11-15 PARETH-40 (UNII: L774F88277)  
SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23)  
DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82691-145-001 in 1 CARTON04/01/2020
1120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2020
Labeler - RV Skincare LLC (080986653)

Revised: 11/2023
Document Id: 09898669-2893-e17b-e063-6294a90a45c7
Set id: 1e94e04e-e264-44d2-991c-d6229cf034b0
Version: 3
Effective Time: 20231106
 
RV Skincare LLC