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

Soleil Superieur Broad Spectrum SPF 50 Sunscreen US by

Drug Labeling and Warnings

Soleil Superieur Broad Spectrum SPF 50 Sunscreen US by is a Otc medication manufactured, distributed, or labeled by RV Skincare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

SOLEIL SUPERIEUR BROAD SPECTRUM SPF 50 SUNSCREEN US 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82691-146
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82691-146-00	1 in 1 CARTON	12/01/2017
1		50 mL in 1 BOTTLE, PUMP; 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	12/01/2017

Labeler - RV Skincare LLC (080986653)