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 |
|---|---|
| 5A68WGF6WM | Internal UNII lookup |
| 4Y5P7MUD51 | 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 |
|---|---|---|---|---|---|---|
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 241 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | a100b05a-06b7-4c65-9822-3f62ca029f40 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 331 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | c3dd293c-8819-4406-af60-41b632a8c00f | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 342 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | 99a92fc5-9a3e-434a-9a5b-3cc47efeea53 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 351 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | e6cd9c7a-29ef-4132-a3e5-575dddb36a9e | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 421 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | ea630f2c-49a7-4900-a0ac-b0e1c554aff9 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 430 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | cc9c9b69-a0ea-44ac-a590-2cd241ce3162 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 442 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | e38a10a8-73ac-4fc5-bbde-537ccb845e6f | 2026-01-22 | Warnings | M020 |
| Designer Lip Smoothie SPF 15 Lip Balm | AVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUM | Australian Gold | 6fd1bd4f-ef94-42b5-a26c-2a02718c113f | 2026-01-22 | Warnings | M020 |
| Australian Gold SPF 15 Lip Balm | OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLY | Australian Gold | 92966c2d-b61a-4f8b-a5c1-8dfb6352c82f | 2026-01-22 | Warnings | M020 |
| LEBELAGE UV SUN ULTRA SHIELD SUN SCREENLOTION 50g | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATE | DONGDONGGURIMOO CO.,LTD. | 4907eb9c-3978-27ed-e063-6394a90a9f66 | 2026-01-22 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | be9f7608-cfaa-4b16-83dd-0580047af56c | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 6b27df44-c441-4ae8-a1b0-a9cf2fff6f21 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3c295f6b-6202-a2e1-e063-6394a90a9a60 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | b2eee48f-b644-403c-a57e-04a1491bc386 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | ebcc2c6c-a039-48d5-8c1c-5b347254c4c2 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 6967f8bc-3092-44a9-926a-6c11676425e5 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 37d4d8c1-e76b-48a3-9a13-f0543af1b28f | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | fa5046f2-a6db-4ac3-a78f-1b5df075d7e8 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 0c5fc63f-1899-4406-944a-1cdcdf8b4277 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 58a84ecd-3f27-40fc-8e0b-e29192679e6b | 2026-01-21 | 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 |