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 182 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEEai-jr 286, Incb69a75e0-8724-35ae-e053-2a95a90a5f342025-10-07WarningsExact identifier
application number: M020
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
application number: M020
SPF50 SunscreenSUNSCREENKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDb3cde609-7d62-2ac7-e053-2a95a90a26b32025-10-07Exact identifier
application number: M020
Summer Face Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESUMMER GELEE LLCfe256ff4-cb92-4262-8ab9-7cc912e0af222025-10-06WarningsExact identifier
application number: M020
Sun Veil Broad Spectrum SPF50ZINC OXIDEMONAT GLOBAL CORP3ba28de7-74a2-5cde-e063-6394a90add262025-10-06WarningsExact identifier
application number: M020
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEToshiki Pigment Co., Ltd.b9eba15f-493a-43c9-e053-2995a90a04512025-10-06WarningsExact identifier
application number: M020
Apple Lip Balm with Aloe VeraBROAD SPECTRUM SPF 15 SUNSCREEN LIP BALMDurvet, Inc.6dcbb2cd-e690-4970-8cf1-08ca539d36022025-10-06WarningsExact identifier
application number: M020
PURE SOL SPF 50 Daily MoisturizerZINC OXIDEBrand 2022b LLC4051506c-fc13-cd22-e063-6394a90a977e2025-10-04WarningsExact identifier
application number: M020
PURE SOL SPF 30 Mineral Whipped Sunscreen (Shimmer)ZINC OXIDEBrand 2022b LLC4051ced5-85cf-6211-e063-6394a90a09fc2025-10-04WarningsExact identifier
application number: M020
PURE SOL SPF 30 Mineral Whipped SunscreenZINC OXIDEBrand 2022b LLC4051d241-6890-2b06-e063-6294a90aa09d2025-10-04WarningsExact identifier
application number: M020
PURE SOL SPF 37 Tinted MoisturizerZINC OXIDE TITANIUM DIOXIDEBrand 2022b LLC4052c4e4-2105-80c0-e063-6294a90af41d2025-10-04WarningsExact identifier
application number: M020
PLAY Antioxidant Body Mist SPF 50 - Vanilla OrchidAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3f7a9722-d211-e861-e063-6294a90a6cdc2025-10-02WarningsExact identifier
application number: M020
Kids Mineral Sunscreen SPF50SUNSCREENHello Bello01cc554b-9241-d891-e063-6394a90a84502025-10-02WarningsExact identifier
application number: M020
HydroGlow Daily Sunscreen BROAD SPECTRUM SPF 50 UVA and UVBSUNSCREEN SPF 50IHerb, LLC3cab1598-5ef3-df73-e063-6394a90ab1e22025-10-01WarningsExact identifier
application number: M020
Moisturizing Rich Sunscreen SPF 30ZINC OXIDEGood Molecules, LLC36c3ba26-ca25-7498-e063-6294a90a47fc2025-10-01WarningsExact identifier
application number: M020
Wonderscreen Broad Spectrum SPF 30 Shade 1ZINC OXIDEDime Beauty Co, LLC07104cbf-0446-a053-e063-6394a90ab41f2025-10-01WarningsExact identifier
application number: M020
Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3ZINC OXIDEDime Beauty Co, LLC07503a1f-d530-e3bb-e063-6294a90a8ae32025-10-01WarningsExact identifier
application number: M020
Wonderscreen Broad Spectrum SPF 30ZINC OXIDEDime Beauty Co, LLCe38deed3-e1e2-0b1d-e053-2a95a90a547f2025-10-01WarningsExact identifier
application number: M020
Wonderscreen Tinted Broad Spectrum SPF 30ZINC OXIDEDime Beauty Co, LLCf2a59fa4-f19c-a15f-e053-2a95a90a6ace2025-10-01WarningsExact identifier
application number: M020
Bronzing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC414b88ca-a3df-5e42-e063-6294a90a69ba2025-10-01WarningsExact 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