NDC | 42851-050-04, 42851-151-04 |
Set ID | a514c884-3e7b-4c1a-9a9d-f5fe891cd288 |
Category | HUMAN OTC DRUG LABEL |
Packager | ZO Skin Health, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions) decreases the risk of of skin cancer and early aging caused by the sun.
- Warnings
-
Directions
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months: Ask a doctor
-
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
- Other information
-
Inactive ingredients
Water (Aqua), Caprylic/Capric Triglyceride, Glycerin, C12-15 Alkyl Benzoate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Pentylene Glycol, Polysorbate 60, Cetyl Alcohol, Stearic Acid, Dimethicone, Phenoxyethanol, Ceteth-10 Phosphate, Dicetyl Phosphate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Ethylhexyl Palmitate, Aminomethyl Propanol, Butylene Glycol, Fragrance (Parfum), Panthenol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium PCA, Sodium Lactate, Capryloyl Glycine, Dipotassium Glycyrrhizate, Laminaria Ochroleuca Extract, Sodium Ascorbate, Tocopherol, Undecylenoyl Glycine, Arginine, Aspartic Acid, Disodium EDTA, PCA, Retinol, Carbomer, Glycine, Silica Dimethyl Silylate, Alanine, Polysorbate 20, Serine, Valine, Isoleucine, Proline, Threonine, Diacetyl Boldine, Histidine, Phenylalanine, Sodium Hyaluronate, Ubiquinone, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
-
INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT AND PREVENT AGING HANDS
avobenzone, octinoxate, and oxybenzone kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-151 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-151-04 1 in 1 CARTON 04/01/2013 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 JAR 15 g Part 2 1 TUBE 40 mL Part 3 1 TUBE 40 mL Part 1 of 3 ZO SKIN HEALTH ORASER MICRODERM HAND RENEWAL
cleansing (cold creams, cleansing lotions, liquids, and pads) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR SUCROSE (UNII: C151H8M554) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR SAFFLOWER OIL (UNII: 65UEH262IS) INGR MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) INGR DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z) INGR GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) INGR TRIBEHENIN (UNII: 8OC9U7TQZ0) INGR CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR UBIDECARENONE (UNII: EJ27X76M46) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR RETINOL (UNII: G2SH0XKK91) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR MANNITOL (UNII: 3OWL53L36A) INGR POWDERED CELLULOSE (UNII: SMD1X3XO9M) INGR HYPROMELLOSES (UNII: 3NXW29V3WO) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR FRAGARIN (UNII: 0416TL8388) INGR ULTRAMARINE BLUE (UNII: I39WR998BI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 15 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 Cosmetic 01/01/2012 Part 2 of 3 ZO SKIN HEALTH ORASER OVERNIGHT HAND RECOVERY
cleansing (cold creams, cleansing lotions, liquids, and pads) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) INGR MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) INGR STEARIC ACID (UNII: 4ELV7Z65AP) INGR CETYL PHOSPHATE (UNII: VT07D6X67O) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) INGR HEXYLDECANOL (UNII: 151Z7P1317) INGR AVOCADO OIL (UNII: 6VNO72PFC1) INGR AMINOMETHYLPROPANOL (UNII: LU49E6626Q) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) INGR FRAGARIN (UNII: 0416TL8388) INGR CHLORPHENESIN (UNII: I670DAL4SZ) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR UREA (UNII: 8W8T17847W) INGR GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) INGR ALOE (UNII: V5VD430YW9) INGR SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR SODIUM LACTATE (UNII: TU7HW0W0QT) INGR LEVOMENOL (UNII: 24WE03BX2T) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR ARGININE (UNII: 94ZLA3W45F) INGR CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G) INGR ASPARTIC ACID (UNII: 30KYC7MIAI) INGR PIDOLIC ACID (UNII: SZB83O1W42) INGR ETHYLHEXYL PALMITATE (UNII: 2865993309) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR GLYCINE (UNII: TE7660XO1C) INGR ALANINE (UNII: OF5P57N2ZX) INGR RAPESEED STEROL (UNII: B46B6DD20U) INGR SERINE (UNII: 452VLY9402) INGR VALINE (UNII: HG18B9YRS7) INGR DIACETYL BOLDINE (UNII: 37727Z7M0I) INGR ISOLEUCINE (UNII: 04Y7590D77) INGR PROLINE (UNII: 9DLQ4CIU6V) INGR THREONINE (UNII: 2ZD004190S) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR HISTIDINE (UNII: 4QD397987E) INGR PHENYLALANINE (UNII: 47E5O17Y3R) INGR UBIDECARENONE (UNII: EJ27X76M46) INGR SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR RETINOL (UNII: G2SH0XKK91) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 40 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2012 Part 3 of 3 ORASER DAILY HAND REPAIR BROAD-SPECTRUM SPF 20 SUNSCREEN
avobenzone, octinoxate, and oxybenzone lotionProduct Information Item Code (Source) NDC:42851-050 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 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Glycerin (UNII: PDC6A3C0OX) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Shea Butter (UNII: K49155WL9Y) Cetostearyl Alcohol (UNII: 2DMT128M1S) Styrene (UNII: 44LJ2U959V) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Pentylene Glycol (UNII: 50C1307PZG) Polysorbate 60 (UNII: CAL22UVI4M) Cetyl Alcohol (UNII: 936JST6JCN) Stearic Acid (UNII: 4ELV7Z65AP) Dimethicone (UNII: 92RU3N3Y1O) Phenoxyethanol (UNII: HIE492ZZ3T) Ceteth-10 Phosphate (UNII: 4E05O5N49G) Dihexadecyl Phosphate (UNII: 2V6E5WN99N) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) Ethylhexyl Palmitate (UNII: 2865993309) Aminomethylpropanol (UNII: LU49E6626Q) Butylene Glycol (UNII: 3XUS85K0RA) Panthenol (UNII: WV9CM0O67Z) Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Sodium Lactate (UNII: TU7HW0W0QT) Capryloyl Glycine (UNII: 8TY5YO42NJ) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Laminaria Ochroleuca (UNII: 4R2124HE76) Sodium Ascorbate (UNII: S033EH8359) Tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-050-04 40 mL 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 final part352 01/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2013 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations PAKLAB 790530976 MANUFACTURE(42851-151)