REVIVE FERMITIF NECK RENEWAL BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, octinoxate, octocrylene, and oxybenzone cream

ReVive Fermitif Neck Renewal by

Drug Labeling and Warnings

ReVive Fermitif Neck Renewal 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 2.0%	Sunscreen
Octinoxate 6.0%	Sunscreen
Octocrylene 2.7%	Sunscreen
Oxybenzone 2.0%	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

Water, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Cetearyl Alcohol, Squalane, Isocetyl Stearate, Potassium Cetyl Phosphate, PPG-2 Myristyl Ether Propionate, Sorbitan Stearate, Methylsilanol Hydroxyproline Aspartate, Tocopheryl Acetate, sh-Oligopeptide-1, sh-Polypeptide-1, Phenoxyethanol, Terminalia Catappa Leaf Extract, Bisabolol, Dimethicone, Polysorbate 60, Magnesium Aluminum Silicate, Carbomer, Aminomethyl Propanol, Sodium PCA, Allantoin, Caprylyl Glycol, Chlorphenesin, Aloe Barbadensis Leaf Juice, Sambucus Nigra Flower Extract, Disodium EDTA, Fragrance, Glycolipids, PVP, Tannic Acid, Hydrolyzed Soy Flour, Sodium Hyaluronate, Geraniol, Citronellol. May Contain (+/-): Red 33.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 75 g Jar Carton

FERMITIF™
NECK RENEWAL CREAM

RéVive

Broad Spectrum SPF15 Sunscreen

75 g/net wt. 2.5 oz.

INGREDIENTS AND APPEARANCE

REVIVE FERMITIF NECK RENEWAL   BROAD SPECTRUM SPF 15 SUNSCREEN
avobenzone, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-416
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SQUALANE (UNII: GW89575KF9)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
NEPIDERMIN (UNII: TZK30RF92W)
BASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TERMINALIA CATAPPA LEAF (UNII: 4XBZ9J585L)
LEVOMENOL (UNII: 24WE03BX2T)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PYRROLIDONE CARBOXYLIC ACID (UNII: 6VT1YZM21H)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TANNIC ACID (UNII: 28F9E0DJY6)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GERANIOL (UNII: L837108USY)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-416-50	1 in 1 CARTON	02/20/2014
1		75 g in 1 JAR; 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	02/20/2014

Labeler - RéVive Skincare (193691821)