REVIVE FERMITIF HAND RENEWAL BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, octinoxate, and octisalate cream

ReVive Fermitif Hand Renewal by

Drug Labeling and Warnings

ReVive Fermitif Hand 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 3.0%	Sunscreen
Octinoxate 7.5%	Sunscreen
Octisalate 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, Butylene Glycol, Glycerin, C12-15 Alkyl Benzoate, Mangifera Indica (Mango) Seed Butter, Octyldodecyl Neopentanoate, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Aluminum Starch Octenylsuccinate, Hydrogenated Palm Glycerides, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Decapeptide-4, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Sodium Coco PG-Dimonium Chloride Phosphate, Caprylyl Methicone, Squalane, Camellia Sinensis Seed Oil, Caprylyl Glycol, Fragrance, Glyceryl Laurate, Polysilicone-11, Isohexadecane, Carrageenan, Glucose, Polyethylene, Tocopheryl Acetate, Polysorbate 60, Butyrospermum Parkii (Shea) Butter, Jojoba Alcohol, Phenylethyl Resorcinol, Potassium Jojobate, Potassium Sorbate, Propanediol, Simmondsia Chinensis (Jojoba) Butter, Maltodextrin, Disodium EDTA, Pentylene Glycol, Carbomer, Rhodiola Rosea Root Extract, Polysorbate 20, Sodium Hyaluronate, Subtilisin, Citronellol, Geraniol. May Contain (+/-): Red 4, Red 33.

Questions or comments?

Call 1-888-704-3440, M – F 8am – 5pm CST.

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

FERMITIF™
HAND RENEWAL CREAM

RéVive

Broad Spectrum
SPF 15 Sunscreen

100 g / net wt. 3.4 oz.

INGREDIENTS AND APPEARANCE

REVIVE FERMITIF HAND RENEWAL  BROAD SPECTRUM SPF 15 SUNSCREEN
avobenzone, octinoxate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-415
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
SQUALANE (UNII: GW89575KF9)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL LAURATE (UNII: Y98611C087)
ISOHEXADECANE (UNII: 918X1OUF1E)
CARRAGEENAN (UNII: 5C69YCD2YJ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SHEA BUTTER (UNII: K49155WL9Y)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANEDIOL (UNII: 5965N8W85T)
JOJOBA BUTTER (UNII: XIA46H803R)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SUBTILISIN (UNII: 0ZP13EBC5Y)
GERANIOL (UNII: L837108USY)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-415-60	1 in 1 CARTON	10/30/2015
1		100 g in 1 TUBE; 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	10/30/2015

Labeler - RéVive Skincare (193691821)