FDA.reportPublic FDA data

PoutScreen Lip Treatment Chocolate Kiss

Product NDC
81104-604
11-digit product format
811040604
Labeler code
81104
Product ID
81104-604_563e3ab9-4ee3-279c-e063-6294a90a7cf1
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
2026-07-08
Substance
OCTINOXATE; OCTOCRYLENE; AVOBENZONE
Active strength
7.5; 10; 2.5 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 Chocolate Kiss
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100mL
OCTOCRYLENE10 g/100mL
AVOBENZONE2.5 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
563e3ab9-4ee2-279c-e063-6294a90a7cf1Available on FDA.report

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 141 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddc3d7-76df-3344-e063-6294a90a65ae2025-12-09WarningsExact identifier
application number: M020
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddf80c-8496-0f47-e063-6394a90afc182025-12-09WarningsExact identifier
application number: M020
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30dfa973-3217-1e18-e063-6294a90a8d412025-12-09WarningsExact identifier
application number: M020
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30df0039-4dc1-7355-e063-6394a90ae8002025-12-09WarningsExact identifier
application number: M020
Advanced Lip GuardTITANIUM DIOXIDE, ZINC OXIDEADVANCED DERMATOLOGY32e66ff3-ae1a-4a2a-e063-6294a90a79632025-12-09Exact identifier
application number: M020
Skin Tone Defender 20% Zinc OxideZINC OXIDECali Skin Care LLC308c711d-4c3e-1208-e063-6394a90a9cc22025-12-09WarningsExact identifier
application number: M020
Advanced Light Perfecting SunscreenZINC OXIDEADVANCED DERMATOLOGY32d781ca-7993-9875-e063-6294a90a5c262025-12-09Exact identifier
application number: M020
Advanced Light Perfecting SunscreenZINC OXIDEAdvanced Dermatology32e6c080-6ce3-8d99-e063-6294a90ac1bc2025-12-09Exact identifier
application number: M020
StriVectin multi-action Super-C SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.b299df12-fbdd-437b-9bfa-4846e361725a2025-12-09WarningsExact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL.S. MOORE LLC37f1e019-32c4-b733-e063-6394a90aca282025-12-09Exact identifier
application number: M020
RADIANCEZINC OXIDEL.S. MOORE LLC37f254cb-9de5-8f67-e063-6294a90a4e282025-12-09Exact identifier
application number: M020
StriVectin Advanced Retinol Daily Repair Moisturizer SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.cfbdbba8-a739-fd32-e053-2a95a90a6f312025-12-09WarningsExact identifier
application number: M020
Hint of TintZINC OXIDEL.S. MOORE LLC37f20c14-070e-4f86-e063-6294a90ad4c22025-12-09Exact identifier
application number: M020
Hint of TintZINC OXIDEL.S. MOORE LLC37f330a0-790a-1656-e063-6294a90a691c2025-12-09Exact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL.S. MOORE LLC37f2e363-e85f-f601-e063-6294a90ab1202025-12-09Exact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL MOORE AESTHETICS37f1ac8c-3bfb-10da-e063-6294a90a8ca82025-12-09Exact identifier
application number: M020
RoC Multi Correxion Revive and Glow Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare40d4cfeb-fb00-801e-e063-6394a90ada6b2025-12-09WarningsExact identifier
application number: M020
RADIANCEZINC OXIDEL.S. MOORE LLC37f2b104-0213-c88c-e063-6294a90a42472025-12-09Exact identifier
application number: M020
Mineral Sunscreen Moisturizing Lightly TintedZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC3350c673-2afd-a00a-e063-6294a90aa1962025-12-09Exact identifier
application number: M020
Mineral Sunscreen Dry Touch NTTITANIUM DIOXIDE, ZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC334ffc49-3196-0995-e063-6394a90ad5592025-12-09Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81104-604-02811040604021 TUBE, WITH APPLICATOR in 1 CARTON (81104-604-02) / 15 mL in 1 TUBE, WITH APPLICATOR (81104-604-01) 2026-07-08NoNoCurrent