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 332 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRIDEFUL SPF 15 LIP BALM-passion fruitHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCd6b6389b-c8bd-4aca-8ccf-455dbc22070d2023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-coconutHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCa6af5cdc-999d-45ba-a7a6-5e7330f8b9c02023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-melonHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCe201fec6-eb69-40fb-8459-02d64e34a3b72023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-orange mangoHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCc50c9f00-6a0f-4307-b35d-7fc5fa3b7edf2023-10-26WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLCe5fcb1fd-ad61-1ea5-e053-2a95a90a24722023-10-26WarningsExact identifier
application number: M020
Grape Soda SPF 15 Broad Spectrum Lip BalmGRAPE SODA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca09a0b5f-93e4-d18a-e053-2a95a90a65f72023-10-26WarningsExact identifier
application number: M020
Beeswax SPF 30 Broad Spectrum Lip BalmBEESWAX SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Inca962bfca-03a3-8dde-e053-2a95a90abbb92023-10-26WarningsExact identifier
application number: M020
CreamZINC OXIDEOxygen Development LLC08a1e862-b55a-fb84-e063-6294a90a016a2023-10-26WarningsExact identifier
application number: M020
SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDETHE KROGER COMPANYa52872bf-cd0f-06da-e053-2995a90af28d2023-10-26WarningsExact identifier
application number: M020
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08a36887-3997-8fff-e063-6394a90ae9d52023-10-26WarningsExact identifier
application number: M020
PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCe87c4a76-5f21-4989-a1e0-0b7c6902f2012023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Unflavored Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN UNFLAVORED LIP BALMRaining Roseefe20472-aa84-1cb4-e053-2a95a90abfd82023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Mint Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN MINT LIP BALMRaining Roseefe1113b-6101-0c15-e053-2a95a90a02a72023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Tropical Smoothie Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN TROPICAL SMOOTHIE LIP BALMRaining Roseefe176f7-9c11-106e-e053-2a95a90a9c882023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Citrus Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN CITRUS LIP BALMRaining Roseefdfc182-3ac0-1a3d-e053-2a95a90a894e2023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Iced Pear Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN ICED PEAR LIP BALMRaining Roseefe01abd-0ee2-6bd6-e053-2a95a90a123d2023-10-26WarningsExact identifier
application number: M020
Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDENATURA BISSE INTERNATIONAL SAbf8b71c7-257b-0eb6-e053-2a95a90a3a4c2023-10-26WarningsExact identifier
application number: M020
Carmex Weather Guard Moisturizing Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMCarma Laboratories, Inc.843677f2-78fa-4f3d-9fe6-e45e35b728e32023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Cupcake Batter SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baec9be7-5ae6-135c-e053-2995a90a2ed42023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baea3596-6eb0-4d98-e053-2995a90a75cc2023-10-25WarningsExact 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