FDA.reportPublic FDA data

Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn

Product NDC
83247-2489
11-digit product format
832472489
Labeler code
83247
Product ID
83247-2489_52bb47b9-b6d3-213d-e063-6294a90a11df
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Iris and Romeo
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-21
Substance
ZINC OXIDE
Active strength
110 mg/mL
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
Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE110 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52bb700b-ff56-2286-e063-6394a90ac458Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83247-2489-1Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn6.5 mL in 1 BOTTLE, WITH APPLICATORLOTION6.51
83247-2489-2Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn1 in 1 CARTONLOTION11

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 194 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum Broad Spectrum SPF 30 5 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cad0757-3155-c716-e063-6294a90ad7a92025-08-18WarningsExact identifier
application number: M020
Cica Redness Solution SunscreenZINC OXIDEMeebak Beauty, Inc15eea1eb-9468-4611-915d-e43112c4a4f52025-08-18WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE/OCTOCRYLENEEdgewell Personal Care Brands LLC3c936ed0-ab7a-ccec-e063-6294a90afd932025-08-17WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE OCTOCRYLENE OXYBENZONEEdgewell Personal Care Brands LLC0f772b91-e67b-46cf-e054-00144ff8d46c2025-08-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, OCTOCRYLENE, OXYBENZONEEdgewellPersonal Care Brands LLC353353b9-54f8-4300-9632-7615de3940762025-08-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC0c6aeadb-f61d-29e3-e063-6294a90a74732025-08-17WarningsExact identifier
application number: M020
MOISTURE SURGE SPFAVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATECLINIQUE LABORATORIES LLCec921e21-db68-db77-e053-2a95a90a57812025-08-15WarningsExact identifier
application number: M020
Olay Invisible Sunscreen Facial Primer plus Sunscreen Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company3c69f096-1575-309b-e063-6394a90a72292025-08-15WarningsExact identifier
application number: M020
MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCea4d564f-ac64-abac-e053-2a95a90a8abb2025-08-15WarningsExact identifier
application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Sunset Cove CardedHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3ac67c26-d56e-32a9-e063-6294a90a10482025-08-15WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDESun Bum, LLC3aa13423-045a-7227-e063-6294a90ae49b2025-08-15WarningsExact identifier
application number: M020
Sun Bum Daily Sunscreen Mist Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a796a0b-8021-9a9f-e063-6294a90a6eb22025-08-15WarningsExact identifier
application number: M020
SOLARA SUNCARE - DAY DREAMER SPF 30ZINC OXIDESOLARA SUNCARE, INC.3c6c9266-a7ff-19f4-e063-6294a90a60962025-08-15WarningsExact identifier
application number: M020
Sun Bum Mineral 30 Sheer Sunscreen FaceZINC OXIDESun Bum, LLC3b00c2d6-a55d-0a56-e063-6294a90ac4b82025-08-15WarningsExact identifier
application number: M020
Sun Bum Mineral 30 Sunscreen 3 OZZINC OXIDESun Bum, LLC3b014bd6-ba40-9003-e063-6394a90ab4512025-08-15WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 30 Zinc Oxide SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3c6e7e62-4313-cbce-e063-6394a90ac3822025-08-15WarningsExact identifier
application number: M020
Ocean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 SunscreenOCTOCRYLENE, ZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3c6f3e0b-2dff-6dc3-e063-6394a90abb0e2025-08-15WarningsExact identifier
application number: M020
EltaMD UV Daily HydrationOCTISALATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.bfdb266b-9920-4225-84c7-bcbad81fd1c72025-08-15WarningsExact identifier
application number: M020
Sun Bum 70 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC39fb5e66-5172-3b83-e063-6394a90aab2d2025-08-14WarningsExact identifier
application number: M020
Sun Bum Face Cream 50 Premium SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3c57fcf7-7816-8197-e063-6394a90af80a2025-08-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83247-2489-1832472489016.5 mL in 1 BOTTLE, WITH APPLICATOR6.5 mlHistorical
83247-2489-2832472489021 BOTTLE, WITH APPLICATOR in 1 CARTON (83247-2489-2) / 6.5 mL in 1 BOTTLE, WITH APPLICATOR (83247-2489-1) 2025-02-21NoNoCurrent