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 272 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health SPF 70 SunAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy63b420ba-ac69-5670-e053-2a91aa0a864b2024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer SPF 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS PHARMACYc52a7e9b-5401-f6e7-e053-2995a90a95192024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacyc68c3d6a-b656-abaf-e053-2a95a90a48db2024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 45 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyc5e8fcc9-db5c-9ee7-e053-2a95a90ac9402024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 55 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyc617cdec-b489-22d2-e053-2995a90a1ec62024-10-22WarningsExact identifier
application number: M020
TRADER JOES ILLUMINATING DAILY FACIAL SUNSCREEN BROAD SPECTRUM SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company1b7c2f13-81b8-7af5-e063-6294a90a35012024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 50 Beach GuardAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacydf25c35d-6b6d-1ef8-e053-2995a90aaef52024-10-22WarningsExact identifier
application number: M020
CVS Health Kids SPF 50 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYe4581d0e-ce6d-7898-e053-2a95a90a02b52024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 55 Ultra Sheer Face MistAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacydfb55b46-e88f-4949-e053-2995a90adabc2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 30 Clear Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENECVS PHARMACYe4589114-87c5-56b8-e053-2995a90a09342024-10-22WarningsExact identifier
application number: M020
TRADER JOES ENRICH MOISTURIZING FACE BROAD SPECTRUM SPF 15OCTINOXATE, ZINC OXIDETrader Joe's Companya6805675-916c-4a19-b993-d465fcef58a12024-10-22WarningsExact identifier
application number: M020
TRADER JOES FACE AND BODY SUNSCREEN SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company057ac99c-60e8-47c1-a32d-984bbd1818462024-10-22WarningsExact identifier
application number: M020
TRADER JOES ZINC OXIDE MINERAL SUNSCREEN SPF 30ZINC OXIDETrader Joe's Company9e48de83-cb72-4c03-a819-939db8793e1f2024-10-22WarningsExact identifier
application number: M020
TRADER JOES DAILY FACIAL SUNSCREEN SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Companydb3c2210-0e11-0a0e-e053-2a95a90aecbf2024-10-22WarningsExact identifier
application number: M020
Philosophy Hope in a Jar Smooth-glow Multi-tasking Moisturizer Broad Spectrum SPF 30 with Pro-vitamin P, glycolic and hyaluronic acidsAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEPhilosophy, Inc.24ffeef6-ca72-5f30-e063-6394a90a41d12024-10-21WarningsExact identifier
application number: M020
Bali Body BB Cream SPF 15 NaturalOCTOCRYLENE, OCTINOXATE, AVOBENZONE, OXYBENZONEBali Body Pty Ltddb0edf56-4f39-7b48-e053-2a95a90a9b422024-10-21WarningsExact identifier
application number: M020
Bali Body Tinted Super Serum Natural SPF 30OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEBali Body Pty Ltdf5eeaf37-33f2-2c0c-e053-2a95a90abcc02024-10-21WarningsExact identifier
application number: M020
Bali Body BB Cream SPF 15 TanOCTOCRYLENE, OCTINOXATE, AVOBENZONE, OXYBENZONEBali Body Pty Ltddb0f6a36-27dd-3301-e053-2995a90aff652024-10-21WarningsExact identifier
application number: M020
Bali Body Watermelon Tanning Oil SPF 6OCTOCRYLENE, OCTISALATE, AVOBENZONEBali Body Pty Ltd03705641-feaf-2cbd-e063-6394a90a806e2024-10-21WarningsExact identifier
application number: M020
Bali Body Pineapple Tanning Oil SPF15OCTOCRYLENE, OCTISALATE, AVOBENZONEBali Body Pty Ltd21c49bbf-97b1-c8c0-e063-6394a90ab4122024-10-21WarningsExact 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