FDA.reportPublic FDA data

SPF 15 Coconut Lip Balm

Product NDC
84489-026
11-digit product format
844890026
Labeler code
84489
Product ID
84489-026_25a7510f-5ef4-9920-e063-6394a90a2079
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Naples Soap Company, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-02
Substance
ZINC OXIDE
Active strength
35 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SPF 15 Coconut Lip Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE35 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25a7510f-5ef3-9920-e063-6394a90a2079Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84489-026-96SPF 15 Coconut Lip Balm4.2 g in 1 CYLINDERSTICK4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84489-026SPF 15 SPEARMINT LIP BALM (ZINC OXIDE) STICK SPF 15 COCONUT LIP BALM (ZINC OXIDE) STICK [NAPLES SOAP COMPANY, INC.]1Current NDC, 1 package rows20241111_25a7510f-5ef3-9920-e063-6394a90a2079.zip

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 282 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H.E.B Solutions SunscreenSPORT SPF 70 CONTINUOUS SPRAYH.E.Bf9b5b360-6b69-4006-934f-5bc8a9fdfcd02024-10-15WarningsExact identifier
application number: M020
HEBGENERAL PROTECTION SPF 100 LOTIONH-E-B39d94e3a-98c8-44b0-bd2d-f318ac7bbf752024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenWET PROTECTION KIDS SPF 70 CONTINUOUS SPRAYH.E.Bf823b236-5884-41d9-bff0-65b91664aaad2024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenCOOLING SPORT SPF 50 CONTINUOUS SPRAYH.E.B67fdf3a0-08fe-4348-a4f9-a83f3cf46b722024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenULTRA SPF 70 CONTINUOUS SPRAYH.E.Bc16935ce-afdb-4571-b5a3-6dc5d01f721c2024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenBABY SPF 50 LOTION SPRAYH.E.B1082111f-bf04-4a98-b6a0-5da933652f1d2024-10-15WarningsExact identifier
application number: M020
H.E.B ULTRASPF 50 SUNSCREENH.E.Bd6184ba2-0e47-459a-8777-1f27be2140a62024-10-15WarningsExact identifier
application number: M020
H.E.B ULTRASPF 30 SUNSCREENH.E.B90287874-cdfa-489c-936d-e487f6b3db962024-10-15WarningsExact identifier
application number: M020
H.E.BSPF 50 SUNSCREENH.E.B2c9258ac-8cbe-4acf-9c02-bb993d69a3e52024-10-15WarningsExact identifier
application number: M020
H.E.BSPF 50 SUNSCREENH.E.B39bf1379-3dee-4aa0-967a-36faccca42162024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenSPORT SPF 100 CONTINUOUS SPRAYH.E.B301ae7e5-5a60-45d0-8cd5-553ba07db4c52024-10-15WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28CHOMOSALATE, ZINC OXIDERare Beauty, LLC2470d78c-724f-4181-e063-6294a90afeaa2024-10-14WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, ZINC OXIDERare Beauty, LLC2471e0fa-ddc8-1c62-e063-6294a90a44082024-10-14WarningsExact identifier
application number: M020
Walgreens 70 Hydrating Sport Broad Spectrum SPF 70 SunscreenAVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYfa2d08be-f67f-60dd-e053-6294a90adb3f2024-10-14WarningsExact identifier
application number: M020
Walgreens 90 Sport ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYfa2e5b1b-f38f-11fe-e053-6394a90a49882024-10-14WarningsExact identifier
application number: M020
Walgreens 70 Sheer SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYfc635082-0a7a-f160-e053-6394a90abba32024-10-14WarningsExact identifier
application number: M020
WALGREENS SPORT SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalgreen Companya9ee1c60-6091-2229-e053-2995a90aa5282024-10-14WarningsExact identifier
application number: M020
WALGREENS BROAD SPECTRUM SPORT SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYb10bdd6e-aa94-470f-8bbf-ff27a1d819382024-10-14WarningsExact identifier
application number: M020
Walgreens Dry Touch Broad Spectrum SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYc628b15c-5fd2-fa5a-e053-2a95a90a43ac2024-10-14WarningsExact identifier
application number: M020
Walgreens SPF 30 Hydrating ContinuousAVOBENZONE, HOMOSALATE, OCTOCRYLENE,WALGREEN COMPANYc8ae7f1a-d198-6609-e053-2a95a90ad4622024-10-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84489-026-96844890026964.2 g in 1 CYLINDER (84489-026-96) 4.2 g2022-08-02NoNoCurrent