NDC | 62839-1101-1, 62839-1102-1, 62839-1103-1, 62839-1104-1 |
Set ID | 55f79a4b-1654-41f7-b456-50ffdcaae845 |
Category | HUMAN OTC DRUG LABEL |
Packager | NSE Products, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
Uses
- Helps prevent sunburn. Higher SPF gives more sunburn protection
- 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.
- Warning
-
Directions
- Shake well before use. Smooth over face and neck area blending well. Seal with powder if desired.
-
Sunprotection 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 of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. –2p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
- 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.
- Other Information
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Inactive Ingredients
Hamamelis Virginiana (Witch Hazel) Water, Cyclopentasiloxane, Titanium Dioxide (Cl 77891), Cyclomethicone, Dimethicone Crosspolymer, Cyclohexasiloxane, Butylene Glycol, Phenyl Trimethicone, Nylon-12, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, Sodium Chloride, Aloe Barbadensis Leaf Juice, Retinyl Palmitate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Zea Mays (Corn) Oil, Methicone, Dimethicone, Disteardimonium Hectorite, Propylene Carbonate, Disodium EDTA, Fragrance, Phenoxyethanol, Methylparaben, Propylparaben.
- Questions?
- PRINCIPAL DISPLAY PANEL - 40 ml Bottle Carton (Beige)
- PRINCIPAL DISPLAY PANEL - 40 ml Bottle Carton (Fair)
- PRINCIPAL DISPLAY PANEL - 40 ml Bottle Carton (Honey)
- PRINCIPAL DISPLAY PANEL - 40 ml Bottle Carton (Sand)
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INGREDIENTS AND APPEARANCE
NU SKIN NU COLOUR TINTED MOISTURIZER BROAD SPECTRUM SPF 15 BEIGE
octinoxate and octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-1104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 50 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength Hamamelis Virginiana Top Water (UNII: NT00Y05A2V) Cyclomethicone 5 (UNII: 0THT5PCI0R) Titanium Dioxide (UNII: 15FIX9V2JP) Cyclomethicone (UNII: NMQ347994Z) Cyclomethicone 6 (UNII: XHK3U310BA) Butylene Glycol (UNII: 3XUS85K0RA) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Nylon-12 (UNII: 446U8J075B) Hexyl Laurate (UNII: 4CG9F9W01Q) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Sodium Chloride (UNII: 451W47IQ8X) Ferric Oxide Yellow (UNII: EX438O2MRT) Phenoxyethanol (UNII: HIE492ZZ3T) Disteardimonium Hectorite (UNII: X687XDK09L) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Methylparaben (UNII: A2I8C7HI9T) Propylene Carbonate (UNII: 8D08K3S51E) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Propylparaben (UNII: Z8IX2SC1OH) Aloe Vera Leaf (UNII: ZY81Z83H0X) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Corn Oil (UNII: 8470G57WFM) Chromic Oxide (UNII: X5Z09SU859) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-1104-1 1 in 1 CARTON 1 40 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/03/2011 NU SKIN NU COLOUR TINTED MOISTURIZER BROAD SPECTRUM SPF 15 FAIR
octinoxate and octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-1101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 50 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength Hamamelis Virginiana Top Water (UNII: NT00Y05A2V) Cyclomethicone 5 (UNII: 0THT5PCI0R) Titanium Dioxide (UNII: 15FIX9V2JP) Cyclomethicone (UNII: NMQ347994Z) Cyclomethicone 6 (UNII: XHK3U310BA) Butylene Glycol (UNII: 3XUS85K0RA) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Nylon-12 (UNII: 446U8J075B) Hexyl Laurate (UNII: 4CG9F9W01Q) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Sodium Chloride (UNII: 451W47IQ8X) Phenoxyethanol (UNII: HIE492ZZ3T) Disteardimonium Hectorite (UNII: X687XDK09L) Ferric Oxide Yellow (UNII: EX438O2MRT) Methylparaben (UNII: A2I8C7HI9T) Ferric Oxide Red (UNII: 1K09F3G675) Propylene Carbonate (UNII: 8D08K3S51E) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Propylparaben (UNII: Z8IX2SC1OH) Ferrosoferric Oxide (UNII: XM0M87F357) Aloe Vera Leaf (UNII: ZY81Z83H0X) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Corn Oil (UNII: 8470G57WFM) Chromic Oxide (UNII: X5Z09SU859) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-1101-1 1 in 1 CARTON 1 40 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/03/2011 NU SKIN NU COLOUR TINTED MOISTURIZER BROAD SPECTRUM SPF 15 HONEY
octinoxate and octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-1103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 50 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength Hamamelis Virginiana Top Water (UNII: NT00Y05A2V) Cyclomethicone 5 (UNII: 0THT5PCI0R) Titanium Dioxide (UNII: 15FIX9V2JP) Cyclomethicone (UNII: NMQ347994Z) Cyclomethicone 6 (UNII: XHK3U310BA) Butylene Glycol (UNII: 3XUS85K0RA) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Nylon-12 (UNII: 446U8J075B) Hexyl Laurate (UNII: 4CG9F9W01Q) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Sodium Chloride (UNII: 451W47IQ8X) Ferric Oxide Yellow (UNII: EX438O2MRT) Phenoxyethanol (UNII: HIE492ZZ3T) Disteardimonium Hectorite (UNII: X687XDK09L) Ferric Oxide Red (UNII: 1K09F3G675) Methylparaben (UNII: A2I8C7HI9T) Ferrosoferric Oxide (UNII: XM0M87F357) Propylene Carbonate (UNII: 8D08K3S51E) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Propylparaben (UNII: Z8IX2SC1OH) Aloe Vera Leaf (UNII: ZY81Z83H0X) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Corn Oil (UNII: 8470G57WFM) Chromic Oxide (UNII: X5Z09SU859) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-1103-1 1 in 1 CARTON 1 40 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/03/2011 NU SKIN NU COLOUR TINTED MOISTURIZER BROAD SPECTRUM SPF 15 SAND
octinoxate and octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-1102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 50 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength Hamamelis Virginiana Top Water (UNII: NT00Y05A2V) Cyclomethicone 5 (UNII: 0THT5PCI0R) Titanium Dioxide (UNII: 15FIX9V2JP) Cyclomethicone (UNII: NMQ347994Z) Cyclomethicone 6 (UNII: XHK3U310BA) Butylene Glycol (UNII: 3XUS85K0RA) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Nylon-12 (UNII: 446U8J075B) Hexyl Laurate (UNII: 4CG9F9W01Q) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Sodium Chloride (UNII: 451W47IQ8X) Ferric Oxide Yellow (UNII: EX438O2MRT) Phenoxyethanol (UNII: HIE492ZZ3T) Disteardimonium Hectorite (UNII: X687XDK09L) Ferric Oxide Red (UNII: 1K09F3G675) Methylparaben (UNII: A2I8C7HI9T) Ferrosoferric Oxide (UNII: XM0M87F357) Propylene Carbonate (UNII: 8D08K3S51E) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Propylparaben (UNII: Z8IX2SC1OH) Aloe Vera Leaf (UNII: ZY81Z83H0X) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Corn Oil (UNII: 8470G57WFM) Chromic Oxide (UNII: X5Z09SU859) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-1102-1 1 in 1 CARTON 1 40 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/03/2011 Labeler - NSE Products, Inc. (803486393)