REVIVE SOLEIL SUPERIEUR BROAD SPECTRUM SPF 50 SUNSCREEN PA- avobenzone, homosalate, octisalate, and octocrylene cream

ReVive Soleil Superieur Broad Spectrum by

Drug Labeling and Warnings

ReVive Soleil Superieur Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by RéVive Skincare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.00%	Sunscreen
Homosalate 10.00%	Sunscreen
Octisalate 5.00%	Sunscreen
Octocrylene 2.60%	Sunscreen

Uses

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

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
• 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 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton

SOLEIL SUPERIÉUR

RéVive

Broad Spectrum
SPF 50 Sunscreen
PA++++

50 g / net wt. 1.7 oz.

INGREDIENTS AND APPEARANCE

REVIVE SOLEIL SUPERIEUR BROAD SPECTRUM   SPF 50 SUNSCREEN PA
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-420
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
ALCOHOL (UNII: 3K9958V90M)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
SILIBININ (UNII: 4RKY41TBTF)
CARNOSINE (UNII: 8HO6PVN24W)
ADENOSINE (UNII: K72T3FS567)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOHEXADECANE (UNII: 918X1OUF1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PANTHENOL (UNII: WV9CM0O67Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
C11-15 PARETH-40 (UNII: L774F88277)
C11-15 PARETH-7 (UNII: 261HPE0IS3)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)
SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-420-10	1 in 1 CARTON	02/01/2016
1		50 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

Labeler - RéVive Skincare (193691821)