SOLEIL SUPERIEUR BROAD SPECTRUM SPF 50 SUNSCREEN US- avobenzone, homosalate, octisalate, octocrylene cream 
RV Skincare LLC

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Soleil Superieur Broad Spectrum SPF 50 Sunscreen US

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.6%

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), Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Potassium Cetyl Phosphate, Thermus Thermophillus Ferment, PEG-100 Stearate, Glyceryl Stearate, Methyl Glucose Sesquistearate, Alcohol Denat., Oligopeptide-24, Tocopheryl Acetate, Carnosine, Adenosine, Polygonum Aviculare Extract, Glycerin, Panthenol, Tocopherol, Sodium Oleate, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Hydrogenated Palm Glycerides, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetyl Alcohol, Caprylyl Glycol, Isohexadecane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Lecithin, Silybin, Potassium Sorbate, Potassium Hydroxide, Hexylene Glycol, Sorbitan Oleate, Parfum (Fragrance), Dipotassium Glycyrrhizate, C11-15 Alketh-7, C11-15 Alketh-40, Sodium Benzoate, Phenoxyethanol, Polyacrylate-15, Polyacrylate-17, Polysorbate 80, Disodium EDTA, PEG-10 Dimethicone, Disodium Lauryl Sulfosuccinate, Sodium Laureth-12 Sulfate.

Questions or comments?

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

Package Labeling:

Outer Package7Inner Package7Box5

SOLEIL SUPERIEUR BROAD SPECTRUM SPF 50 SUNSCREEN US 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82691-146
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)  
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
ALCOHOL (UNII: 3K9958V90M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARNOSINE (UNII: 8HO6PVN24W)  
ADENOSINE (UNII: K72T3FS567)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM OLEATE (UNII: 399SL044HN)  
SOYBEAN OIL (UNII: 241ATL177A)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SILIBININ (UNII: 4RKY41TBTF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)  
SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82691-146-001 in 1 CARTON12/01/2017
150 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 DrugM02012/01/2017
Labeler - RV Skincare LLC (080986653)

Revised: 11/2023
Document Id: 09899a6b-0e1a-ace4-e063-6394a90a6548
Set id: cf0000e8-98f8-4e36-bbdd-8c301b73b3e1
Version: 3
Effective Time: 20231106
 
RV Skincare LLC