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
5A68WGF6WMInternal UNII lookup
4Y5P7MUD51Internal 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 143 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316b46ac-6dde-72d1-e063-6294a90a03da2025-12-09Exact identifier
application number: M020
ReplenishZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316c43fb-0c15-87d4-e063-6294a90a0a632025-12-09Exact identifier
application number: M020
BIOJUVE Microbiome-Safe Sheer Finish SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesece7565b-f3e5-3386-e053-2a95a90a58022025-12-09WarningsExact identifier
application number: M020
Hydraboost Lip TreatmentAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBluemercury2cf30083-8723-23f6-e063-6394a90a55de2025-12-09WarningsExact identifier
application number: M020
Florida Babe Sport Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31e4756d-8604-6e75-e063-6294a90aebe12025-12-09Exact identifier
application number: M020
Florida Babe Sport Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31e4d9ae-f532-f9f5-e063-6294a90a8d392025-12-09Exact identifier
application number: M020
Arbonne FunSun Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEArbonne International, LLC91bcd120-28e5-4f44-9522-550c1dbcd82c2025-12-09WarningsExact identifier
application number: M020
Florida Babe Active Tinted 20percent Zinc Oxide Mineral SunscreenZINC OXIDETichy Anesthesia PA31e509f2-dcb6-5ae0-e063-6394a90a70c12025-12-09Exact identifier
application number: M020
Florida Babe Active Non-Tinted 20percent Zinc Oxide Mineral SunscreenZINC OXIDETichy Anesthesia PA31e57817-b8c4-8178-e063-6294a90a01492025-12-09Exact identifier
application number: M020
Florida Babe Everyday Tinted Replenishing Daily ProtectionZINC OXIDETichy Anesthesia PA3231f1fe-51b3-b2e7-e063-6394a90a27582025-12-09Exact identifier
application number: M020
Florida Babe Everyday Tinted Replenishing Daily ProtectionZINC OXIDETichy Anesthesia PA31e63876-3e39-adc6-e063-6394a90ab1462025-12-09Exact identifier
application number: M020
Florida Babe SPORT Mineral Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31f5bbe4-5f6e-3bef-e063-6294a90a26462025-12-09Exact identifier
application number: M020
Florida Babe SPORT Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31f54a79-70b7-def5-e063-6294a90a709b2025-12-09Exact identifier
application number: M020
Florida Babe Sport Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA3231b71c-4d27-e5e2-e063-6294a90a031b2025-12-09Exact identifier
application number: M020
Arbonne Soft Focus Veil Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEArbonne International, LLC3c9b605b-5a16-4f89-a956-8c4c62de72d32025-12-09WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE AESTHETICS ACADEMY, LLC364b9560-f7a1-ed8f-e063-6294a90a2c412025-12-09Exact identifier
application number: M020
Sunshield Moisturizing Sunscreen and AntioxidantZINC OXIDEOculofacial Surgery andCosmetic Laser Institute, LLC.32c247fc-d4da-e03d-e063-6394a90a72b02025-12-09Exact identifier
application number: M020
SCALP SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEFOLICULE LLC387b10e1-5443-7b7a-e063-6394a90a2c7a2025-12-09Exact identifier
application number: M020
Sunshield Moisturizing Sunscreen and AntioxidantZINC OXIDEOculofacial Surgery andCosmetic Laser Institute, LLC.32c3936e-4089-edd0-e063-6294a90ad3f82025-12-09Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDETHE AESTHETICS ACADEMY, LLC364cf1f7-1f87-51f7-e063-6294a90a789c2025-12-09Exact 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