FDA.reportPublic FDA data

Peppermint SPF 15 Sunscreen Lip Balm

Product NDC
84489-101
11-digit product format
844890101
Labeler code
84489
Product ID
84489-101_4a1a523c-246b-0cb8-e063-6394a90a93c6
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, octinoxate, octisalate, octocrylene
Dosage form
STICK
Route
TOPICAL
Labeler
Naples Soap Company, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-27
Substance
OCTINOXATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength
7.5; 3; 5; 5 g/100g; g/100g; g/100g; g/100g
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
Peppermint SPF 15 Sunscreen Lip Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100g
AVOBENZONE3 g/100g
OCTOCRYLENE5 g/100g
OCTISALATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
24adffd4-5177-f5d5-e063-6294a90a7850Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84489-101-01Peppermint SPF 15 Sunscreen Lip Balm4.25 g in 1 TUBESTICK4.253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84489-101PEPPERMINT SPF 15 SUNSCREEN LIP BALM (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK [NAPLES SOAP COMPANY, INC.]1Current NDC, 1 package rows20241020_24adffd4-5177-f5d5-e063-6294a90a7850.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
84489-101-01844890101014.25 g in 1 TUBE (84489-101-01) 4.25 g2021-01-27NoNoCurrent