FDA.reportPublic FDA data

Lip Balm with SPF 15 Vanilla Flavored

Product NDC
72449-438
11-digit product format
724490438
Labeler code
72449
Product ID
72449-438_5bd93d28-cb11-a9b3-e063-6394a90afc41
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OXYBENZONE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
LS Promotions INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-19
Substance
OCTINOXATE; OXYBENZONE
Active strength
75; 35 mg/g; 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
Lip Balm with SPF 15 Vanilla Flavored
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/g
OXYBENZONE35 mg/g

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 136 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
illuminating mineral mousseTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35bb4d67-373f-f60c-e063-6394a90a974d2025-12-11Exact identifier
application number: M020
Soft Focus Mineral Defense TintedTITANIUM DIOXIDE, ZINC OXIDESPOTLESS SKIN STUDIO387f1ea9-4764-3abe-e063-6394a90adde02025-12-11Exact identifier
application number: M020
flawless photo finishZINC OXIDENEXTEX CORPORATION35bb0ac4-6abd-ca75-e063-6394a90a26cd2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352efbee-cab4-c515-e063-6294a90a46f22025-12-11Exact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e6e79-94db-dbb1-e063-6394a90aefd62025-12-11Exact identifier
application number: M020
Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f5c53-3075-f437-e063-6394a90a4c4e2025-12-11Exact identifier
application number: M020
PreventionTITANIUM DIOXIDE, ZINC OXIDENoble Center for Healthy Aging LLC387dbf46-4316-a15d-e063-6394a90adeb12025-12-11Exact identifier
application number: M020
Gentle Defense SunscreenZINC OXIDEMint Skin Incroporated352fe5e4-8b3f-248f-e063-6394a90ab42c2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f8de3-8ff0-4098-e063-6294a90ace4d2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incroporated35305bf1-8947-f275-e063-6294a90a30242025-12-11Exact identifier
application number: M020
Gentle Defense SunscreenZINC OXIDEMint Skin Incorporated3530898c-7bdf-6ffe-e063-6394a90aa0372025-12-11Exact identifier
application number: M020
Equate SPF 50 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalmart Inc45b4d41b-c9ac-2c26-e063-6294a90a614f2025-12-11WarningsExact identifier
application number: M020
Mint ConditionZINC OXIDEMint Skin Incorporated353031d7-cc2d-426c-e063-6394a90a99ea2025-12-11Exact identifier
application number: M020
Body ProtectZINC OXIDENoble Center for Healthy Aging LLC387df843-b7d3-df2e-e063-6294a90a93f22025-12-11Exact identifier
application number: M020
Everyday Mineral Tinted SunscreenZINC OXIDEAtlanta Acne Specialists, LLC351e6ca8-c6cb-dd99-e063-6294a90af0cf2025-12-11Exact identifier
application number: M020
Mint ConditionZINC OXIDEMint Skin Incorporated3530efd2-b122-9aba-e063-6394a90a89532025-12-11Exact identifier
application number: M020
The Tinted Mineral SunscreenZINC OXIDEThe Hue Solution L.L.C.37f30a04-8ffa-09de-e063-6294a90aba052025-12-11Exact identifier
application number: M020
Abib Airy clear sunscreen gel Smoothing tubeHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEFourcompany Co., Ltd.33d1a5da-68c3-b16e-e063-6294a90a70062025-12-10WarningsExact identifier
application number: M020
Non Tinted Mineral Moisturizing SunscreenZINC OXIDEABOUT FACE AESTHETICS, INC.3647a985-5365-a9e0-e063-6294a90ac0a42025-12-10Exact identifier
application number: M020
ProtectME Tinted Mineral SPF 40 20%ZINC OXIDEPUREFECTION LA, INC.33dd1afa-25a8-891f-e063-6294a90a8c8a2025-12-10Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72449-438-01724490438011 BAG in 1 CASE (72449-438-01) / 750 TUBE in 1 BAG / 4.2 g in 1 TUBE1 bag2026-09-19NoNoCurrent