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 |
|---|---|
| OCTINOXATE | 7.5 g/100mL |
| AVOBENZONE | 2.5 g/100mL |
| OCTOCRYLENE | 10 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 47d22c6d-49fd-f97c-e063-6294a90a6ba1 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81104-596-01 | PoutScreen Lip Treatment Midnight Kiss | 15 mL in 1 TUBE, WITH APPLICATOR | LIQUID | 15 | 1 | |
| 81104-596-02 | PoutScreen Lip Treatment Midnight Kiss | 1 in 1 CARTON | LIQUID | 1 | 1 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BabyGanics Sunscreen 30 SPF | ZINC OXIDE, OCTINOXATE, AND OCTISALATE | KAS Direct LLC dba BabyGanics | 391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAIN | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299ac9a5-f609-d804-e063-6394a90abd05 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORY | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299ad424-16a8-66b1-e063-6394a90a0753 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDE | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299afef9-758f-74e1-e063-6294a90a8072 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGE | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299b3276-7973-d33f-e063-6294a90a6ce1 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TAN | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299afe24-d496-5745-e063-6394a90aa1b3 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGE | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299b1f9a-34fd-cb50-e063-6394a90af925 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SAND | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299b3236-3f3d-c9e8-e063-6394a90a7443 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNY | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 299b416d-ce02-3462-e063-6294a90a38f0 | 2024-12-19 | Warnings | M020 |
| Puttisu | TITANIUM DIOXIDE, ZINC OXIDE | Jellycup, Inc. | a032331a-6724-d2cd-e053-2995a90ac15a | 2024-12-19 | Warnings | M020 |
| Dr. C. Tuna Resurface Essential Day Cream SPF 30 | HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE | Farmasi US LLC | de493e30-d135-9def-e053-2995a90ae49a | 2024-12-19 | Warnings | M020 |
| toty Ilumina CC Cream 1N | TITANIUM DIOXIDE, ZINC OXIDE | Chipican LLC | e4efe14e-7d46-78c0-e053-2995a90a2364 | 2024-12-19 | Warnings | M020 |
| Aruba Sun SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | d8b28ce6-e938-c6e3-e053-2a95a90acc29 | 2024-12-19 | Warnings | M020 |
| DCH Pain Relief Roll-On | LIDOCAINE HCL 4% | Derma Care Research Labs, LLC | fda35d37-f36e-efc8-e053-6294a90a2bb8 | 2024-12-19 | Warnings | M020 |
| Black Girl Sunscreen SPF 50 Kids | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | d53ff8f5-0b06-1e8b-e053-2a95a90ab924 | 2024-12-19 | Warnings | M020 |
| Fresh Coast SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | 043cadde-ba07-7c77-e063-6394a90abee6 | 2024-12-19 | Warnings | M020 |
| Black Girl Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8% | Derma Care Research Labs, LLC | d438be95-0f88-69d7-e053-2995a90a982e | 2024-12-19 | Warnings | M020 |
| Pavin SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | e945f9df-0aed-469c-e053-2995a90ab6aa | 2024-12-19 | Warnings | M020 |
| Bee Bald Smooth Plus Daily Moisturizer SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 6% | Derma Care Research Labs, LLC | 051b68f9-5d6b-3cd7-e063-6394a90aeb35 | 2024-12-19 | Warnings | M020 |
| MKMen Advanced Facial Hydrator Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Mary Kay Inc. | 484e92db-09a2-4e93-aa7e-d91dbda31555 | 2024-12-19 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 81104-596-01 | 81104059601 | 15 mL in 1 TUBE, WITH APPLICATOR | 15 ml | Historical | |||
| 81104-596-02 | 81104059602 | 1 TUBE, WITH APPLICATOR in 1 CARTON (81104-596-02) / 15 mL in 1 TUBE, WITH APPLICATOR (81104-596-01) | 2025-12-18 | No | No | Current |