Broad Spectrum SPF 15 Sunscreen Mint Lip Balm

Product NDC
65692-0571
11-digit product format
656920571
Labeler code
65692
Product ID
65692-0571_08a48426-8790-5d99-e063-6394a90a505c
Type
HUMAN OTC DRUG
Nonproprietary name
Broad Spectrum SPF 15 Sunscreen Mint Lip Balm
Dosage form
STICK
Route
TOPICAL
Labeler
Raining Rose
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-13
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OCTISALATE
Active strength
.13; .28; .06; .21 g/4.25g; g/4.25g; g/4.25g; g/4.25g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Broad Spectrum SPF 15 Sunscreen Mint Lip Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE.13 g/4.25g
OCTINOXATE.28 g/4.25g
OCTOCRYLENE.06 g/4.25g
OCTISALATE.21 g/4.25g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal 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
efe1113b-6101-0c15-e053-2a95a90a02a7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-0571-1Broad Spectrum SPF 15 Sunscreen Mint Lip Balm4.25 g in 1 TUBESTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0571BROAD SPECTRUM SPF 15 SUNSCREEN MINT LIP BALM STICK [RAINING ROSE]2Current NDC, 1 package rows20231027_efe1113b-6101-0c15-e053-2a95a90a02a7.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 185 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUR 4-in-1 Skin Tint DG6ZINC OXIDEPUR Minerals3f8e97a7-2023-ba9c-e063-6294a90ac9c92025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN7ZINC OXIDEPUR Minerals3f0717c7-f43f-e3b1-e063-6394a90a74dd2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN2ZINC OXIDEPUR Minerals3f06ed2f-f43f-53d4-e063-6294a90af0dd2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint MN4ZINC OXIDEPUR Minerals3f06f618-f7b2-53d0-e063-6294a90a829c2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint MN3ZINC OXIDEPUR Minerals3f06df49-5ed2-44ca-e063-6294a90a1fda2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint LN2ZINC OXIDEPUR Minerals3f069dfe-289d-8d3b-e063-6394a90a04962025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint LG3ZINC OXIDEPUR Minerals3f06ec3e-fc15-9f7b-e063-6394a90a07332025-09-24WarningsExact identifier
application number: M020
Volition Prismatic Luminizing ShieldZINC OXIDEVolition1a633c24-b9d9-4732-e063-6294a90af4c02025-09-24WarningsExact identifier
application number: M020
Alleyoop Sunsational Broad SpectrumZINC OXIDENewAlley Innovations Inc248419c4-8044-402c-e063-6394a90a00f82025-09-24WarningsExact identifier
application number: M020
Aloe Up SPF 30 coco-mango mistAVOBENZONE 3.0%, HOMOSALATE 7.5%, OCTISALATE 5.0%Aloe Upf7b2d4a2-3a0d-4239-b7e5-8de2f6ac2e922025-09-24WarningsExact identifier
application number: M020
pavise Dynamic Age DefenseZINC OXIDEB.A.I BIOSCIENCES, INCf4e9f95c-6b1e-d5f7-e053-2a95a90a93ce2025-09-24WarningsExact identifier
application number: M020
Aloe Up SPF 50 coco-mango mistAVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%Aloe Upd535b711-c54e-4447-9907-ca9d829d13192025-09-24WarningsExact identifier
application number: M020
ESPOIR WATER SPLASH SUN SERUMHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEESPOIR Corporation1c4e7ba2-05e8-f949-e063-6394a90a699d2025-09-23WarningsExact identifier
application number: M020
Banana BoatZINC OXIDEEdgewell Personal Care Brands LLC1d11c3d0-5f4e-0ed0-e063-6294a90abc752025-09-23WarningsExact identifier
application number: M020
Dewscreen Daily Hydrator and Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3f7c84e3-0e4f-b7e9-e063-6294a90a12952025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Gel Gel Sunscreen Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15d8574d-94bb-4842-e063-6394a90a15e62025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15da0cb1-e695-cec3-e063-6394a90a1afa2025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Face Liquid Sunscreen Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15daac41-54b6-096d-e063-6294a90a07362025-09-23WarningsExact identifier
application number: M020
Mtn. Bum by Sun Bum and Mcfetridge Mineral Sunscreen Face Stick SPF 50ZINC OXIDESun Bum, LLC3f8101b1-297d-2ad8-e063-6294a90a9cff2025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Glow Tinted Sunscreen Moisturizer Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESun Bum, LLC20c48752-3ad9-5993-e063-6294a90ae1b02025-09-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65692-0571-1656920571014.25 g in 1 TUBE (65692-0571-1) 4.25 g2022-12-13NoNoCurrent