REVIVE MOISTURIZING RENEWAL- avobenzone and octinoxate cream

REVIVE MOISTURIZING RENEWAL by

Drug Labeling and Warnings

REVIVE MOISTURIZING RENEWAL by is a Otc medication manufactured, distributed, or labeled by REVIVE 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

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, Cyclopentasiloxane, Glycerin, Caprylic/Capric Triglyceride, Triolein, Butylene Glycol, Pentylene Glycol, Oleyl Erucate, Thermus Thermophillus Ferment, Cetearyl Alcohol, Glyceryl Stearate, Dimethicone, Hydrogenated Polyisobutene, Isopropyl Isostearate, PEG-100 Stearate, Sodium Hyaluronate, Tocopheryl Acetate, Tocopherol, Chondrus Crispus Extract, Oligopeptide-41, Oligopeptide-24, Microcrystalline Cellulose, C14-22 Alcohols, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Tetrahexyldecyl Ascorbate, Cetyl Alcohol, Allantoin, Carnosine, Disodium EDTA, Lecithin, C12-20 Alkyl Glucoside, PEG-75 Stearate, Inulin Lauryl Carbamate, Silybin, Cellulose Gum, Ethylhexylglycerin, Cetearyl Glucoside, Polysorbate 60, Ceteth-20, Steareth-20, Adenosine, Sorbitan Isostearate, t-Butyl Alcohol, Gluconolactone, Glyceryl Citrate/Lactate/Linoleate/Oleate, Vegetable Oil/Olus Oil, Glucose, Potassium Sorbate, Glycine Soja (Soybean) Oil, Sodium Oleate, Hydrogenated Lecithin, Fragrance, BHT, Phenoxyethanol, Sodium Benzoate, Geraniol, Hexyl Cinnamal, Hydroxycitronellal.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

MOISTURIZING
RENEWAL CREAM

RéVive

Broad Spectrum SPF 15 Sunscreen

50 g / net wt. 1.7 oz.

INGREDIENTS AND APPEARANCE

REVIVE MOISTURIZING RENEWAL 
avobenzone and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-352
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1500 mg  in 50 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3746 mg  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Glycerin (UNII: PDC6A3C0OX)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Glyceryl Trioleate (UNII: O05EC62663)
Butylene Glycol (UNII: 3XUS85K0RA)
Pentylene Glycol (UNII: 50C1307PZG)
Oleyl Erucate (UNII: 753W099NQ6)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Dimethicone (UNII: 92RU3N3Y1O)
Hydrogenated Polybutene (1300 Mw) (UNII: 7D1YQ9Y5EZ)
Isopropyl Isostearate (UNII: C67IXB9Y7T)
PEG-100 Stearate (UNII: YD01N1999R)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
.Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
Chondrus Crispus Carrageenan (UNII: UE856F2T78)
Microcrystalline Cellulose (UNII: OP1R32D61U)
C14-22 Alcohols (UNII: B1K89384RJ)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)
Squalane (UNII: GW89575KF9)
Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Cetyl Alcohol (UNII: 936JST6JCN)
Allantoin (UNII: 344S277G0Z)
Carnosine (UNII: 8HO6PVN24W)
Edetate Disodium (UNII: 7FLD91C86K)
C12-20 Alkyl Glucoside (UNII: K67N5Z1RUA)
PEG-75 Stearate (UNII: OT38R0N74H)
Silibinin (UNII: 4RKY41TBTF)
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
Ethylhexylglycerin (UNII: 147D247K3P)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Polysorbate 60 (UNII: CAL22UVI4M)
Ceteth-20 (UNII: I835H2IHHX)
Steareth-20 (UNII: L0Q8IK9E08)
Adenosine (UNII: K72T3FS567)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Tert-Butyl Alcohol (UNII: MD83SFE959)
Gluconolactone (UNII: WQ29KQ9POT)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Soybean Oil (UNII: 241ATL177A)
Sodium Oleate (UNII: 399SL044HN)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Benzoate (UNII: OJ245FE5EU)
Geraniol (UNII: L837108USY)
.Alpha.-Hexylcinnamaldehyde (UNII: 7X6O37OK2I)
Hydroxycitronellal (UNII: 8SQ0VA4YUR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-352-50	1 in 1 CARTON	10/01/2017
1		50 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	10/01/2017

Labeler - REVIVE SKINCARE (193691821)