FDA.reportPublic FDA data

PoutScreen Lip Treatment Midnight Kiss

Product NDC
81104-596
11-digit product format
811040596
Labeler code
81104
Product ID
81104-596_47d2360a-0b96-1e45-e063-6294a90a97ae
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, Octocrylene
Dosage form
LIQUID
Route
TOPICAL
Labeler
NAKED SUNDAYS PTY LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-18
Substance
OCTINOXATE; AVOBENZONE; OCTOCRYLENE
Active strength
7.5; 2.5; 10 g/100mL; g/100mL; g/100mL
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
PoutScreen Lip Treatment Midnight Kiss
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100mL
AVOBENZONE2.5 g/100mL
OCTOCRYLENE10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47d22c6d-49fd-f97c-e063-6294a90a6ba1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81104-596-01PoutScreen Lip Treatment Midnight Kiss15 mL in 1 TUBE, WITH APPLICATORLIQUID151
81104-596-02PoutScreen Lip Treatment Midnight Kiss1 in 1 CARTONLIQUID11

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 92 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f4599b-de62-2bc7-e063-6394a90a69ab2025-12-31WarningsExact identifier
application number: M020
Hawaiian Tropic Everyday Active SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc8e2ee8-e67f-ef5d-e053-2995a90a15202025-12-31WarningsExact identifier
application number: M020
Sunscreen Glowing, SPF 30SUNSCREEN GLOWING LOTIONCardinal Health, Inc28ed3b60-1139-f657-e063-6394a90a52fa2025-12-31WarningsExact identifier
application number: M020
Sunscreen Setting Spritz, SPF 45SUNSCREEN SETTING SPRAYCardinal Health, inc.293e9656-8644-b9aa-e063-6294a90a5b272025-12-31WarningsExact identifier
application number: M020
Sunscreen Setting Spritz, SPF 45SUNSCREEN SETTING SPRAYFSA Store Inc473d6804-8d20-6899-e063-6294a90a31312025-12-31WarningsExact identifier
application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47428cd4-fbad-ba7a-e063-6394a90a1c5c2025-12-31WarningsExact identifier
application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47433a62-91e0-b031-e063-6294a90a0d492025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4743b6a9-4d79-1b2b-e063-6394a90a97102025-12-31WarningsExact identifier
application number: M020
Royal Jelly Radiance Foundation Broad Spectrum SPF 20 EarthOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.0edc7bd4-9350-48e1-bbfe-e6450458ae592025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - BronzeOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.90fbf555-106c-4131-b572-ead9bbb246e62025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - HoneyOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.1accbe67-c722-4af7-8422-0559ac4a987a2025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - BareOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5c0805c7-9b92-4c08-877c-64e7203084302025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20- NaturalOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.0cc5429d-ace4-4060-b993-1b607218eaf82025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20-NudeOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.b1851c5d-32ad-482a-bd24-2f280a68ef9e2025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 -SpiceOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.6164dc23-81c2-48b8-b309-2c5a81fe13a42025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4744e501-f12a-6d25-e063-6394a90a25742025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - TawnyOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.d7c4e758-3af2-40c6-bbe1-37e6fd0a5eb62025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - CappuccinoOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.30601a73-089e-4fa7-8fb7-6b108498934a2025-12-31WarningsExact identifier
application number: M020
Good Karma Dry Oil Mineral Sunscreen SPF-30ZINC OXIDE SUNSCREENSOLARA SUNCARE, INC.209c4913-29e6-24ca-e063-6294a90a68722025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47456bf5-9f6c-e6a5-e063-6294a90a70542025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81104-596-018110405960115 mL in 1 TUBE, WITH APPLICATOR15 mlHistorical
81104-596-02811040596021 TUBE, WITH APPLICATOR in 1 CARTON (81104-596-02) / 15 mL in 1 TUBE, WITH APPLICATOR (81104-596-01) 2025-12-18NoNoCurrent