FDA.reportPublic FDA data

Lemonade SPF 15 Broad Spectrum Lip Balm

Product NDC
65692-0529
11-digit product format
656920529
Labeler code
65692
Product ID
65692-0529_086810e8-468b-f9d2-e063-6394a90a583b
Type
HUMAN OTC DRUG
Nonproprietary name
Lemonade SPF 15 Broad Spectrum Lip Balm
Dosage form
STICK
Route
TOPICAL
Labeler
Raining Rose, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-17
Substance
OCTISALATE; AVOBENZONE; OCTOCRYLENE; OCTINOXATE
Active strength
.21; .09; .06; .28 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
Lemonade SPF 15 Broad Spectrum Lip Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE.21 g/4.25g
AVOBENZONE.09 g/4.25g
OCTOCRYLENE.06 g/4.25g
OCTINOXATE.28 g/4.25g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8ffc32b-b758-0f8f-e053-2995a90adb62Available 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
65692-0529-1Lemonade SPF 15 Broad Spectrum Lip Balm4.25 g in 1 TUBESTICK4.253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0529LEMONADE SPF 15 BROAD SPECTRUM LIP BALM STICK [RAINING ROSE, INC]3Current NDC, Legacy NDC, 1 package rows20231024_a8ffc32b-b758-0f8f-e053-2995a90adb62.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 108 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avail Facial Sunscreen SPF 25HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEEmeis Cosmetics Pty Ltd7be903e4-5f07-35b2-e053-2991aa0a13402025-12-17WarningsExact identifier
application number: M020
Mineral Sheer StickZINC OXIDESupergoop, LLC0beed72e-51df-d15a-e063-6394a90af5592025-12-17WarningsExact identifier
application number: M020
Sunscreen Lotion118mlZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4620c41a-2188-00f5-e063-6394a90a613c2025-12-17WarningsExact identifier
application number: M020
Sunscreen CreamZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46224dbe-a0fb-c242-e063-6394a90a26342025-12-17WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 0NENSULIZOLE, OCTISALATEParfums Christian Dior31141a45-54e2-4463-ab42-4df56d9116502025-12-17WarningsExact identifier
application number: M020
Perricone High Potency Face Finishing and Firming MoisturizerTITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC2409cea1-7077-dc12-e063-6294a90a45582025-12-17WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC3635a073-5484-f96c-e063-6394a90adef52025-12-17Exact identifier
application number: M020
Mineral Sunscreen LipTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC36362dc7-31d7-f766-e063-6294a90a129b2025-12-17Exact identifier
application number: M020
Mineral Sunscreen Non-TintedZINC OXIDEGlow Advanced Skin and Body Care, LLC3635e45b-6978-ac69-e063-6294a90a22ac2025-12-17Exact identifier
application number: M020
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski36480f7f-37e8-decd-e063-6394a90ada602025-12-17Exact identifier
application number: M020
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski364827bd-5781-eb53-e063-6394a90ab22f2025-12-17Exact identifier
application number: M020
non-tinted face mineral sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649bf1a-17c3-fe0b-e063-6294a90a13c02025-12-17Exact identifier
application number: M020
Tinted Mattifying Face Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649f634-8bcd-b3c1-e063-6394a90a49d92025-12-17Exact identifier
application number: M020
tinted face and body mineral sunscreen SPF40ZINC OXIDELisa Nadler Skin Care and Waxing364a1edd-56e1-55f0-e063-6294a90a45a62025-12-17Exact identifier
application number: M020
non-tinted face and body mineral sunscreen SPF40ZINC OXIDELisa Nadler Skin Care and Waxing364a8c8d-df84-e568-e063-6394a90aaff12025-12-17Exact identifier
application number: M020
tinted lip mineral sunscreen SPF45TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing364b023b-4a52-225a-e063-6394a90ad1972025-12-17Exact identifier
application number: M020
ULTAMATTE PROTECTION SUNSCREENTITANIUM DIOXIDE, ZINC OXIDESKINFINITY37efc466-17b8-9f7b-e063-6294a90a8c882025-12-17Exact identifier
application number: M020
ULTRA SILK PROTECTION SUNSCREENZINC OXIDESKINFINITY383ea760-d55e-a32a-e063-6294a90aa3d22025-12-17Exact identifier
application number: M020
Bella Blu Skin Care Non Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f67134c-88e8-8513-e063-6294a90aaf5a2025-12-17WarningsExact identifier
application number: M020
Bella Blu Skin Care Non Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f66d2ae-00e7-608c-e063-6294a90a49c62025-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65692-0529-1656920529014.25 g in 1 TUBE (65692-0529-1) 4.25 g2020-02-170000-00-00NoNoCurrent