FDA.reportPublic FDA data

SPF 15 Lip Balm Key Lime

Manufacturer
Private Label Select Ltd CO
Effective date
2020-12-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:01

Label at a glance#

ProductSPF 15 Lip Balm Key Lime
Active ingredientZINC OXIDE
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

OTC Active IngredientsOTC Active Ingredients

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

OTC - PURPOSE

OTC - PURPOSE SECTION

OTC PurposeOTC Purpose

ARTWORK - OUTSIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OUTSIDE - ARTWORKOUTSIDE - ARTWORK

ARTWORK - INSIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INSIDE - ARTWORKINSIDE - ARTWORK

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62932-225-382022-01-28C16284748780-1d6a99b39-4d76-a426-e053-dadaa90af4c2Beauty By Earth SPF 15 Lip Balm Key Lime

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62932-225-38SPF 15 Lip Balm Key Lime4.2 g in 1 CONTAINERSTICK4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62932-225SPF 15 LIP BALM KEY LIME STICK [PRIVATE LABEL SELECT LTD CO]1Legacy NDC, 1 package rows20201229_b78ea3c7-eaf9-edc1-e053-2a95a90a34e3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62932-22562932-225-38

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
SHEA BUTTERK49155WL9YIACT
.DELTA.-TOCOPHEROLJU84X1II0NIACT
ZINC OXIDESOI2LOH54ZACTIB
WHITE WAX7G1J5DA97FIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT OILQ9L0O73W7LIACT
RASPBERRY SEED OIL9S8867952AIACT
COCOA BUTTER512OYT1CRRIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
.BETA.-TOCOPHEROL9U6A490501IACT
JOJOBA OIL724GKU717MIACT
TAMANU OILJT3LVK84A1IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
.GAMMA.-TOCOPHEROL8EF1Z1238FIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b78ea3c7-eafa-edc1-e053-2a95a90a34e3b78ea3c7-eaf9-edc1-e053-2a95a90a34e32020-12-28Exact identifier
spl id: b78ea3c7-eafa-edc1-e053-2a95a90a34e3
spl set id: b78ea3c7-eaf9-edc1-e053-2a95a90a34e3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.