FDA.reportPublic FDA data

Nu Skin Sunright Lip Balm Broad Spectrum SPF 15

Product NDC
62839-0369
11-digit product format
628390369
Labeler code
62839
Product ID
62839-0369_386a8750-6142-4090-ae22-0e991803203e
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Octocrylene
Dosage form
STICK
Route
TOPICAL
Labeler
NSE Products, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-01
Marketing end
2026-07-01
Substance
OCTINOXATE; OCTOCRYLENE
Active strength
75; 27.9 mg/mL; mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nu Skin Sunright Lip Balm Broad Spectrum SPF 15

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/mL
OCTOCRYLENE27.9 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 5A68WGF6WM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62839-0369-12020-01-31C16284748780-19d75b9d0-72fa-f424-e053-dadaa90a57ceNu Skin ® Sunright ® Lip Balm Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62839-0369-1Nu Skin Sunright Lip Balm Broad Spectrum SPF 151 in 1 POUCHSTICK13
62839-0369-1Nu Skin Sunright Lip Balm Broad Spectrum SPF 1515 mL in 1 TUBESTICK153

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51NU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
OctocryleneACTIVE INGREDIENT5A68WGF6WMNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
OctinoxateACTIVE MOIETY4Y5P7MUD51NU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
OctocryleneACTIVE MOIETY5A68WGF6WMNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L0NU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
AvobenzoneINACTIVE INGREDIENTG63QQF2NOXNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
Candelilla WaxINACTIVE INGREDIENTWL0328HX19NU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
Castor OilINACTIVE INGREDIENTD5340Y2I9GNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
Chlorella VulgarisINACTIVE INGREDIENTRYQ4R60M02NU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
Ethyl VanillinINACTIVE INGREDIENTYC9ST449YJNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
EthylhexylglycerinINACTIVE INGREDIENT147D247K3PNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
High Density PolyethyleneINACTIVE INGREDIENTUG00KM4WR7NU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7UNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
Octyldodecyl NeopentanoateINACTIVE INGREDIENTX8725R883TNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4NU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
Soybean OilINACTIVE INGREDIENT241ATL177ANU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
Sunflower OilINACTIVE INGREDIENT3W1JG795YINU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
TocopherolINACTIVE INGREDIENTR0ZB2556P8NU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2
Yellow WaxINACTIVE INGREDIENT2ZA36H0S2VNU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62839-0369NU SKIN SUNRIGHT LIP BALM BROAD SPECTRUM SPF 15 (OCTINOXATE AND OCTOCRYLENE) STICK [NSE PRODUCTS, INC.]2Current NDC, Legacy NDC, 2 package rows20140708_255de256-7a58-4226-8ee8-8d72624dcff4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62839-0369-1628390369011 TUBE in 1 POUCH (62839-0369-1) / 15 mL in 1 TUBE1 tube2014-07-012026-07-01NoNoHistorical