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
5A68WGF6WMInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
G63QQF2NOXInternal 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 241 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Future Youth Daily Turnaround Hydrating Moisturizer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEPacifica Beauty, LLC0324275f-13bc-e7b8-e063-6294a90a69022025-01-03WarningsExact identifier
application number: M020
Glow Baby Super Lit SPF 30ZINC OXIDEPacifica Beauty, LLCf3d3eee2-a5d9-113b-e053-2995a90a70572025-01-03WarningsExact identifier
application number: M020
Kind Tint SPF 30ZINC OXIDEPacifica Beauty, LLCf421cbf7-cfae-5eae-e053-2995a90ab35c2025-01-03WarningsExact identifier
application number: M020
Vegan Collagen Every Day SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEPacifica Beauty, LLCf449da32-5ade-2c78-e053-2a95a90a27a12025-01-03WarningsExact identifier
application number: M020
Members Mark SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESam's West Inc2b354ab6-f241-676f-e063-6394a90a58932025-01-03WarningsExact identifier
application number: M020
Vanilla Mint Lip BalmLIP BALMCasad Company Inc.3214bff3-e133-43ca-946d-f4c5dd0747602025-01-03WarningsExact identifier
application number: M020
Vanilla Lip BalmLIP BALMCasad Company Inc.d27398d3-98b0-4f70-997e-6ed02559594f2025-01-03WarningsExact identifier
application number: M020
Cherry Lip BalmLIP BALMCasad Company Inc.b262645e-f069-420d-90ac-9eb4b82236d82025-01-03WarningsExact identifier
application number: M020
Peppermint Lip BalmLIP BALMCasad Company Inc.46a4b6d1-37e4-471d-a41b-57afe8bd9f2f2025-01-03WarningsExact identifier
application number: M020
Beeswax Lip BalmLIP BALMCasad Company Inc.5301398d-82f8-495e-b3ec-0938eca163692025-01-03WarningsExact identifier
application number: M020
Spearmint Lip BalmLIP BALMCasad Company Inc.ba9b5420-60b0-4528-9898-a0a5287a2aee2025-01-03WarningsExact identifier
application number: M020
Pomegranate Lip BalmLIP BALMCasad Company Inc.4e943a8a-f627-4e28-bdd7-c2b63be5dca32025-01-03WarningsExact identifier
application number: M020
Tropical Lip BalmLIP BALMCasad Company Inc.5e730d21-b810-4b84-9c85-0343ab0c8d5a2025-01-03WarningsExact identifier
application number: M020
Green Defense Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEFarmacy Beauty LLCadf0f50f-6357-bc1f-e053-2a95a90ad9972025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 BambooZINC OXIDEEVER FAME PTE. LTD.2abbc7fb-ea5d-9c68-e063-6394a90a88d22025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 AlmondZINC OXIDEEVER FAME PTE. LTD.2abbd076-825d-df76-e063-6294a90a22fc2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ButterZINC OXIDEEVER FAME PTE. LTD.2abbf4a1-a404-b36c-e063-6394a90a41a82025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ButterscotchZINC OXIDEEVER FAME PTE. LTD.2abc0d57-cf8b-2508-e063-6294a90a8ee02025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 CappuchinoZINC OXIDEEVER FAME PTE. LTD.2abc72f5-d1fd-c4f4-e063-6394a90aab9a2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 CamelZINC OXIDEEVER FAME PTE. LTD.2abc3ffb-ce18-6a64-e063-6294a90a8ab12025-01-02WarningsExact 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