Label: NU SKIN SUNRIGHT 35 BROAD SPECTRUM SPF 35- titanium dioxide and zinc oxide lotion
- NDC Code(s): 62839-1344-1
- 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 January 14, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
-
Use
- 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.
- Warnings
-
Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
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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.
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Inactive Ingredients
Acrylates/Dimethicone Copolymer, C12-15 Alkyl Benzoate, Allantoin, Aloe Barbadensis Leaf Juice, Bisabolol, Caprylic/Capric Triglyceride, Caprylyl Methicone, Carthamus Tinctorius (Safflower) Seed Oil, Chlorphenesin, Cyclopentasiloxane, Di-C12-13 Alkyl Tartrate, Dicaprylyl Carbonate, Diglycerin, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Fragrance (Parfum), Haematococcus Pluvialis Extract, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Panthenol, Phenoxyethanol, Physalis Angulata Extract, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Propylene Carbonate, Propylheptyl Caprylate, Silica, Sodium Chloride, Sodium Citrate, Stearalkonium Hectorite, Tocopherol, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Water (Aqua).
- Other Information
- Questions?
- PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
-
INGREDIENTS AND APPEARANCE
NU SKIN SUNRIGHT 35 BROAD SPECTRUM SPF 35
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-1344 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 42 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 45 mg in 1 mL Inactive Ingredients Ingredient Name Strength Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Allantoin (UNII: 344S277G0Z) Aloe Vera Leaf (UNII: ZY81Z83H0X) Levomenol (UNII: 24WE03BX2T) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Caprylyl Trisiloxane (UNII: Q95M2P1KJL) Safflower Oil (UNII: 65UEH262IS) Chlorphenesin (UNII: I670DAL4SZ) Cyclomethicone 5 (UNII: 0THT5PCI0R) Di-C12-13 Alkyl Tartrate (UNII: 603USX4K0G) Dicaprylyl Carbonate (UNII: 609A3V1SUA) Diglycerin (UNII: 3YC120743U) Dimethicone (UNII: 92RU3N3Y1O) Haematococcus Pluvialis (UNII: 31T0FF0472) Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA) Panthenol (UNII: WV9CM0O67Z) Phenoxyethanol (UNII: HIE492ZZ3T) Physalis Angulata whole (UNII: W4TKW9D5GG) Propylene Carbonate (UNII: 8D08K3S51E) Propylheptyl Caprylate (UNII: 991Z19V2OD) Silicon Dioxide (UNII: ETJ7Z6XBU4) Sodium Chloride (UNII: 451W47IQ8X) Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR) Stearalkonium Hectorite (UNII: OLX698AH5P) Tocopherol (UNII: R0ZB2556P8) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-1344-1 1 in 1 CARTON 04/23/2014 1 100 mL in 1 BOTTLE, PLASTIC; 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 04/23/2014 Labeler - NSE Products, Inc. (803486393)