Label: NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - ALMOND- octinoxate, octisalate, and octocrylene lotion
NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - BEIGE- octinoxate, octisalate, and octocrylene lotion
NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - DELICATE IVORY- octinoxate, octisalate, and octocrylene lotion
NU .......ne) lotion
NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - SUNNY BEIGE- octinoxate, octisalate, and octocrylene lotion
NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - SUNSET BEIGE- octinoxate, octisalate, and octocrylene lotion
NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - TAWNY- octinoxate, octisalate, and octocrylene lotion
-
NDC Code(s):
62839-0853-1,
62839-0854-1,
62839-0855-1,
62839-0856-1, view more62839-0857-1, 62839-0858-1, 62839-0859-1, 62839-0860-1, 62839-0861-1, 62839-0862-1, 62839-0863-1, 62839-0864-1, 62839-0865-1, 62839-0866-1, 62839-0867-1
- Packager: NSE Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 26, 2019
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 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.
-
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 broadspectrum SPF 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.
- Apply liberally 15 minutes before sun exposure.
- Other Information
-
Other Ingredients
Water (Aqua), Butylene Glycol, C12-15 Alkyl Benzoate, Glycerin, Isostearic Acid, Glyceryl Stearate, Stearic Acid, Cetyl Alcohol, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Sodium PCA, Panthenol, Bisabolol, Morus Alba Root Extract, Squalane, Tocopheryl Acetate, Jojoba Esters, Tocopherol, Glycine Soja (Soybean) Oil, Nylon-12 Fluorescent Brightener 230 Salt, Dipalmitoyl Hydroxyproline, Niacinamide, Dimethicone, Magnesium Aluminum Silicate, Sodium C14-16 Olefin Sulfonate, Xanthan Gum, Polyvinylalcohol Crosspolymer, Sodium Dehydroacetate, Aminomethyl Propanol, Caprylyl Glycol, Phenoxyethanol.
- Questions?
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Almond
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Beige
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Delicate Ivory
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Honey Beige
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Medium Beige
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Medium Ochre
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Mocha
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral Beige
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Ochre
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Pink
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Pink Ochre
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Soft Beige
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Sunny Beige
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Sunset Beige
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Tawny
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INGREDIENTS AND APPEARANCE
NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - ALMOND
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0857 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0857-1 1 in 1 CARTON 10/27/2014 1 30 mL in 1 BOTTLE, GLASS; 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 10/27/2014 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - BEIGE
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0862 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0862-1 1 in 1 CARTON 08/01/2016 1 30 mL in 1 BOTTLE, GLASS; 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 08/01/2016 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - DELICATE IVORY
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0855 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0855-1 1 in 1 CARTON 08/01/2016 1 30 mL in 1 BOTTLE, GLASS; 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 08/01/2016 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - HONEY BEIGE
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0861 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0861-1 1 in 1 CARTON 08/01/2016 1 30 mL in 1 BOTTLE, GLASS; 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 08/01/2016 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - MEDIUM BEIGE
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0867 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Ferric Oxide Yellow (UNII: EX438O2MRT) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0867-1 1 in 1 CARTON 10/27/2014 1 30 mL in 1 BOTTLE, GLASS; 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 10/27/2014 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - MEDIUM OCHRE
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0866 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Ferric Oxide Yellow (UNII: EX438O2MRT) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0866-1 1 in 1 CARTON 10/27/2014 1 30 mL in 1 BOTTLE, GLASS; 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 10/27/2014 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - MOCHA
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0860 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Glycerin (UNII: PDC6A3C0OX) Titanium Dioxide (UNII: 15FIX9V2JP) Isostearic Acid (UNII: X33R8U0062) Ferric Oxide Yellow (UNII: EX438O2MRT) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0860-1 1 in 1 CARTON 08/01/2016 1 30 mL in 1 BOTTLE, GLASS; 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 08/01/2016 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - NEUTRAL BEIGE
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0853 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0853-1 1 in 1 CARTON 08/01/2016 1 30 mL in 1 BOTTLE, GLASS; 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 08/01/2016 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - OCHRE
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0863 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0863-1 1 in 1 CARTON 10/27/2014 1 30 mL in 1 BOTTLE, GLASS; 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 10/27/2014 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - PINK
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0864 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0864-1 1 in 1 CARTON 10/27/2014 1 30 mL in 1 BOTTLE, GLASS; 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 10/27/2014 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - PINK OCHRE
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0865 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0865-1 1 in 1 CARTON 10/27/2014 1 30 mL in 1 BOTTLE, GLASS; 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 10/27/2014 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - SOFT BEIGE
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0854 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0854-1 1 in 1 CARTON 10/27/2014 1 30 mL in 1 BOTTLE, GLASS; 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 10/27/2014 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - SUNNY BEIGE
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0856 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0856-1 1 in 1 CARTON 10/27/2014 1 30 mL in 1 BOTTLE, GLASS; 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 10/27/2014 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - SUNSET BEIGE
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0858 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Titanium Dioxide (UNII: 15FIX9V2JP) Glycerin (UNII: PDC6A3C0OX) Isostearic Acid (UNII: X33R8U0062) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0858-1 1 in 1 CARTON 08/01/2016 1 30 mL in 1 BOTTLE, GLASS; 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 08/01/2016 NU SKIN NU COLOUR ADVANCED FINISH BROAD SPECTRUM SPF 15 - TAWNY
octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0859 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Glycerin (UNII: PDC6A3C0OX) Titanium Dioxide (UNII: 15FIX9V2JP) Isostearic Acid (UNII: X33R8U0062) Ferric Oxide Yellow (UNII: EX438O2MRT) Glyceryl Monostearate (UNII: 230OU9XXE4) Stearic Acid (UNII: 4ELV7Z65AP) Cetyl Alcohol (UNII: 936JST6JCN) Aloe Vera Leaf (UNII: ZY81Z83H0X) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Panthenol (UNII: WV9CM0O67Z) Levomenol (UNII: 24WE03BX2T) Morus Alba Root (UNII: CST1G9BZGD) Squalane (UNII: GW89575KF9) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tocopherol (UNII: R0ZB2556P8) Soybean Oil (UNII: 241ATL177A) Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H) Niacinamide (UNII: 25X51I8RD4) Dimethicone (UNII: 92RU3N3Y1O) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Xanthan Gum (UNII: TTV12P4NEE) Sodium Dehydroacetate (UNII: 8W46YN971G) Aminomethylpropanol (UNII: LU49E6626Q) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0859-1 1 in 1 CARTON 10/27/2014 1 30 mL in 1 BOTTLE, GLASS; 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 10/27/2014 Labeler - NSE Products, Inc. (803486393)
