FDA.reportPublic FDA data

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 175 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AussieZinc Mineral Sunscreen Vegan and Organic Hydrate and Nourish - Medium TintZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36ca1103-b9bf-2573-e063-6394a90acdc52025-10-23WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Extra SensitiveZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36ca5334-fd41-297f-e063-6394a90ac72e2025-10-23WarningsExact identifier
application number: M020
Mineral Sun DropsZINC OXIDESynchronicity Spa, Inc. DBA Suntegrityd8acda81-4430-42f8-be56-d28bb010e6302025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 LatteOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc34c1486-fa6c-485f-80b3-98e397b3dddb2025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool VanillaOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS74c078ec-a371-4406-8d5e-a0baada3a1a62025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 SandalwoodOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2765f345-eab2-4878-b1f1-f8e2430834762025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 ToffeeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASd1181543-07ab-4a51-8b55-afc1a98293f62025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc7be3a7e-f031-4ec0-b9dc-41c025cd00662025-10-22WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC41c0c262-21c3-b8e6-e063-6394a90a7c9c2025-10-22WarningsExact identifier
application number: M020
PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENESMASHBOX BEAUTY COSMETICS, INC41c4e135-c6df-82d4-e063-6294a90a0ad32025-10-22WarningsExact identifier
application number: M020
City Sunscreen serum Broad Spectrum SPF 30 SupergoopHOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.a29e5a69-d17e-45ef-8dde-e99c6e4a2b222025-10-22WarningsExact identifier
application number: M020
Miffy Sunny Defense SPF StickHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERBGROUP Co., Ltd24802b17-c0ba-1075-e063-6394a90addd52025-10-21WarningsExact identifier
application number: M020
Sunny Defense SPF StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd18632155-5feb-5759-e063-6294a90ab88c2025-10-21WarningsExact identifier
application number: M020
Paul Frank Sunny Defense SPF StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd26345203-3393-60ba-e063-6394a90a7e922025-10-21WarningsExact identifier
application number: M020
Keith Haring Tone Blur Essence SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERBGROUP Co., Ltd1d578196-c785-9914-e063-6394a90a05332025-10-21WarningsExact identifier
application number: M020
luminous aqua sunscreen mistAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd29fc0c2b-8d10-8704-e063-6394a90ad5042025-10-21WarningsExact identifier
application number: M020
DEWYTREE URBAN SHADE HYALURONIC LIGHTWEIGHT SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEDEWYTREE CO. ,LTD2f1ca6e0-f689-57c7-e063-6394a90a3da52025-10-21WarningsExact identifier
application number: M020
TOSOWOONG Rice Glow SunScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMANTONG Co., Ltd.3e9120fd-1c2f-1546-e063-6394a90a9e462025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - BuffHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.857666da-2b4a-4a4a-aa25-ed6fd9b6a1632025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - IvoryHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V62031860-2e28-4b25-82bd-29b874b24d842025-10-21WarningsExact 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