NDC | 10477-7720-1, 10477-7720-2, 10477-7720-3 |
Set ID | ce1156c7-110e-46c1-bbfe-19f12a72b71c |
Category | HUMAN OTC DRUG LABEL |
Packager | Goodier Cosmetics LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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Revision Multi-Protection Broad-Spectrum SPF 50
Multi-Protection
Broad-Spectrum
SPF 50daily oil-free anti-aging
moisturizer with sunscreen
NET WT 1.7 OZ | 48 gActive ingredient Purpose
Avobenzone 3% ........... Sunscreen
Homosalate 3% ............ Sunscreen
Octinoxate 7.5% .......... Sunscreen
Octisalate 4% ............... SunscreenUses
• 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 sunDirections
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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: Ask a doctorInactive ingredientsWater (Aqua), C12-15 Alkyl Ethylhexanoate, Cyclopentasiloxane, Cetearyl Alcohol, Polyglyceryl-3-Methylglucose Distearate, Boron Nitride,
Hydrogenated Starch Hydrolysate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Tetrahexyldecyl Ascorbate, Yeast Extract
(Faex), Camellia Sinensis (Green Tea) Leaf Extract, Epigallocatechin Gallate, Betula Alba (White Birch) Bark Extract, Biosaccharide Gum-1,
Ubiquinone, Cetyl Dimethicone, Palmitoyl Tripeptide-5, Squalane, Sodium Hyaluronate, Palmitoyl Dipeptide-5 Diaminobutyroyl
Hydroxythreonine, Punica Granatum (Pomegranate) Extract, Plankton Extract, Steareth-20, Tocopheryl Acetate, Allantoin, Lecithin,
Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Glyceryl Caprylate, Carbomer, Leuconostoc/Radish Root Ferment Filtrate,
Tocopherol, Steareth-10, Jojoba Bean Meal, Disodium EDTA, Magnesium Chloride, Potassium Sorbate, Fragrance (Parfum). -
Revercel AM Moisturizing Sunscreen Broad Spectrum SPF 50
Active ingredient Purpose
Avobenzone 3% ........... Sunscreen
Homosalate 3% ............ Sunscreen
Octinoxate 7.5% .......... Sunscreen
Octisalate 4% ............... SunscreenUses
• 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 sunDirections
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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: Ask a doctorInactive ingredients
Water (Aqua), C12-15 Alkyl Ethylhexanoate, Cyclopentasiloxane, Cetearyl Alcohol, Polyglyceryl-3-Methylglucose Distearate,
Boron Nitride, Sorbitol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Tetrahexyldecyl Ascorbate, Palmitoyl
Tripeptide-5, Glyceryl Caprylate, Leuconostoc/Radish Root Ferment Filtrate, Cetyl Dimethicone, Tocopherol, Squalane,
Steareth-20, Jojoba Bean Meal, Allantoin, Plankton Extract, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Lecithin,
Sodium Hyaluronate, Betula Alba (White Birch) Bark Extract, Punica Granatum (Pomegranate) Extract, Yeast Extract (Faex),
Biosaccharide Gum-1, Tocopheryl Acetate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Epigallocatechin
Gallate, Camellia Sinensis (Green Tea) Leaf Extract, Ubiquinone, Magnesium Chloride, Carbomer, Disodium EDTA, Steareth-10,
Potassium Sorbate, Fragrance (Parfum) - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAILY MOISTURIZING ANTIOXIDANT SPF 50
avobenzone, homosalate, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10477-7720 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BORON NITRIDE (UNII: 2U4T60A6YD) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) YEAST (UNII: 3NY3SM6B8U) GREEN TEA LEAF (UNII: W2ZU1RY8B0) EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL) BETULA PUBESCENS BARK (UNII: 3R504894L9) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) UBIDECARENONE (UNII: EJ27X76M46) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) SQUALANE (UNII: GW89575KF9) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073) POMEGRANATE (UNII: 56687D1Z4D) STEARETH-20 (UNII: L0Q8IK9E08) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALLANTOIN (UNII: 344S277G0Z) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) TOCOPHEROL (UNII: R0ZB2556P8) STEARETH-10 (UNII: FD0913P475) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) EDETATE DISODIUM (UNII: 7FLD91C86K) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10477-7720-1 1 in 1 CARTON 06/26/2013 1 48 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10477-7720-2 227 g in 1 TUBE; Type 0: Not a Combination Product 06/26/2013 3 NDC:10477-7720-3 3 g in 1 TUBE; Type 0: Not a Combination Product 06/26/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/26/2013 Labeler - Goodier Cosmetics LLC (007317209) Registrant - Goodier Cosmetics LLC (007317209) Establishment Name Address ID/FEI Business Operations Goodier Cosmetics LLC 007317209 manufacture(10477-7720)