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 232 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d0856cf-d3da-5a77-e063-6294a90ad5b42025-01-31WarningsExact identifier
application number: M020
FRE PROTECT BODY Ultra-Light Gel Cream SPF 50ZINC OXIDEPeer Pharm Ltd.2cd83c55-851c-089e-e063-6294a90ad6bc2025-01-30WarningsExact identifier
application number: M020
FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50ZINC OXIDEPeer Pharm Ltd.2cd958a3-bad6-725e-e063-6294a90a85782025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT CASSIS SPF 30ZINC OXIDEPeer Pharm Ltd.2cd77d62-77df-f3a9-e063-6394a90ad57d2025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT PAMPELONNE SPF 30ZINC OXIDEPeer Pharm Ltd.2caf3b6b-3a05-b24a-e063-6394a90a47992025-01-30WarningsExact identifier
application number: M020
Jil Goorman Skincare Sun Guard SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY9a088bed-3b85-4bf5-923b-4c99eb904a8d2025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30ZINC OXIDEPeer Pharm Ltd.2baf0278-7e13-4db0-e063-6294a90ae9de2025-01-30WarningsExact identifier
application number: M020
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc.08a175ae-2307-ef8d-e063-6394a90ad2342025-01-30WarningsExact identifier
application number: M020
Babo Botanicals Super Shield Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc08b7bcfd-0c7c-a14f-e063-6294a90a77972025-01-30WarningsExact identifier
application number: M020
Salt and Stone Sunscreen Lip Balm SPF 30ZINC OXIDESalt and Stone LLCb555aa10-1547-63cc-e053-2995a90ad20d2025-01-30WarningsExact identifier
application number: M020
COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIROCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDEBluemercury5c590aed-d2f2-4478-8919-37c848752b422025-01-29WarningsExact identifier
application number: M020
LiProtect SPF 35ZINC OXIDE, TITANIUM DIOXIDEScience of Skincare0d0a2657-4098-3c60-e063-6294a90acabb2025-01-29WarningsExact identifier
application number: M020
Perfect Sunscreen Tinted Mineral SPF50ZINC OXIDEBluemercury, Inc.4c978154-679f-472a-95ab-56878c5c70cd2025-01-29WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBELLE MEDICAL LLC2cdc69d3-2192-7a38-e063-6294a90a257f2025-01-29WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBoxbar Beauty LLC2d04c5e7-f3aa-873f-e063-6294a90a33d22025-01-29WarningsExact identifier
application number: M020
SEAWEED BATH CO. Super Sheer Face Serum SPF-50ZINC OXIDEThe Seaweed Bath Co.a45b46f9-681f-4a8d-b561-165b995ccf802025-01-28WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc62961-dcef-d7db-e063-6394a90a9ebd2025-01-28WarningsExact identifier
application number: M020
Every Sun Day Ultra-Sheer Priming Sunscreen StickAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEHave & Be Co., Ltd.2b53aa68-9c05-1682-e063-6294a90a968c2025-01-28WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc73c4f-30ea-0a51-e063-6394a90ac9a42025-01-28WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc84aba-006b-a78e-e063-6294a90ae0402025-01-28WarningsExact 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