Search by Drug Name or NDC

NDC 62839-1344-01 Nu Skin Sunright 35 Broad Spectrum SPF 35 42; 45 mg/mL; mg/mL Details

Nu Skin Sunright 35 Broad Spectrum SPF 35 42; 45 mg/mL; mg/mL

Nu Skin Sunright 35 Broad Spectrum SPF 35 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by NSE Products, Inc.. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	62839-1344
Product ID	62839-1344_64b34bac-87cc-4849-aa41-f6c400f96ff9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Nu Skin Sunright 35 Broad Spectrum SPF 35
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide and Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	42; 45
Active Ingredient Units	mg/mL; mg/mL
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	NSE Products, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62839-1344-01 (62839134401)

Pricing Information	N/A
NDC Package Code	62839-1344-1
Billing NDC	62839134401
Package	1 BOTTLE, PLASTIC in 1 CARTON (62839-1344-1) / 100 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2014-04-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 11d83621-2abb-49bc-bdc6-887d450c753e Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Titanium Dioxide 4.2%, Zinc Oxide 4.5%.

Purpose

Sunscreen

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

For external use only.

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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
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.

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

Protect this product from excessive heat and direct sun.

Questions?

1-888-742-7626

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

NU SKIN®

SUNRIGHT® 35

BROAD SPECTRUM

SPF 35

Face & Body

Sunscreen

Water Resistant

(80 minutes)

100 ml e (3.4 fl. oz.)

Principal Display Panel - 100 mL Bottle Carton

INGREDIENTS AND APPEARANCE

NU SKIN SUNRIGHT 35 BROAD SPECTRUM SPF 35

titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62839-1344
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/23/2014

Labeler - NSE Products, Inc. (803486393)

Revised: 1/2022

Document Id: 64b34bac-87cc-4849-aa41-f6c400f96ff9

Set id: 11d83621-2abb-49bc-bdc6-887d450c753e

Version: 3

Effective Time: 20220114