Label: REVIVE MOISTURIZING RENEWAL- avobenzone and octinoxate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 58411-352-50 - Packager: REVIVE SKINCARE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 9, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
-
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
- For sunscreen use:
- Other information
-
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?
- PRINCIPAL DISPLAY PANEL - 50 g Jar Carton
-
INGREDIENTS AND APPEARANCE
REVIVE MOISTURIZING RENEWAL
avobenzone and octinoxate creamProduct 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)
