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 305 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrator Plus SPF 30BROAD SPECTRUMCP Skin Health Group, Inc.b6c0db82-9fba-6216-e053-2a95a90a75602024-02-14WarningsExact identifier
application number: M020
REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/OOCTINOXATE, TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10f7ec01-541b-a15a-e063-6294a90aa9df2024-02-09WarningsExact identifier
application number: M020
SunscreenHOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONESafetec of America, Inc.754186c8-3c88-40a0-a4e3-35e3ea9d1b4c2024-02-08WarningsExact identifier
application number: M020
MIAMI BEACH BUM SPF-50 Blocked SunscreenZINC OXIDEMIAMI BEACH BUM2cf40d87-626b-4309-8f13-fd980161c62f2024-02-07WarningsExact identifier
application number: M020
Equate Sunscreen for All Skin Tones SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWAL-MART INC.1062060a-a5c7-1805-e063-6294a90ab8022024-02-02WarningsExact identifier
application number: M020
Equate Kids Sunscreen Broad Spectrum SPF 50 EquateAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWAL-MART INC.10631036-0fa6-b3ee-e063-6294a90af7aa2024-02-02WarningsExact identifier
application number: M020
Death Tan SPF 50 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEDerma Care Research Labs, LLC106ab5e2-e134-b81d-e063-6294a90a5bca2024-02-02WarningsExact identifier
application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden HourTITANIUM DIOXIDECOOLA, LLCedfda0f5-0f72-5cc7-e053-2a95a90ae38d2024-02-02WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Summer CrushZINC OXIDECOOLA, LLCedc6754e-dabb-5bff-e053-2a95a90a73902024-02-02WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Skinny DipZINC OXIDECOOLA, LLCee01f936-81a9-a54d-e053-2a95a90a52272024-02-02WarningsExact identifier
application number: M020
toty Solaria MineralTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe9d590d8-e71a-0715-e053-2a95a90a5acf2024-02-01WarningsExact identifier
application number: M020
THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50ZINC OXIDELG H&H Co., Ltd.10d343c8-f0c1-6b90-e063-6294a90a24ba2024-02-01WarningsExact identifier
application number: M020
THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50ZINC OXIDEfmg Co.Ltd10d401af-fd92-d82a-e063-6294a90a9f7f2024-02-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum SPF 60 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc18f05adb-43a8-47e5-bc5a-fbf3209d0a442024-01-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum SPF 60 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production03593e3c-c98a-43af-82bc-10331e23342c2024-01-31WarningsExact identifier
application number: M020
ATOMY SUNHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANEATOMY CO., LTD.bdf0a11d-3563-4b09-a430-f031709cb3f32024-01-30WarningsExact identifier
application number: M020
ATOMY DERMA CALMING SUNTITANIUM DIOXIDEATOMY CO., LTD.fd5fc3ba-6e7c-4e48-8e65-47c03141df452024-01-30WarningsExact identifier
application number: M020
EltaMD UV Lip Balm SPF31ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health, Inc0ec70f0a-cda4-4953-b056-e1e6e9921e5b2024-01-25WarningsExact identifier
application number: M020
BBW SPF 35 Natural Lip BalmBBW SPF 35 NATURAL LIP BALMAutumn Harp0f8b024c-c481-951b-e063-6394a90ac63c2024-01-22WarningsExact identifier
application number: M020
Bath and Body Works SPF 35 Natural Lip BalmBATH AND BODY WORKS SPF 35 NATURAL LIP BALMBath and Body Works, Inc.0f8dab80-c84f-ffbd-e063-6294a90a317e2024-01-22WarningsExact 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