Standard Procedure Lip Balm SPF 50
- Product NDC
- 84425-105
- 11-digit product format
- 844250105
- Labeler code
- 84425
- Product ID
- 84425-105_4862ec5d-eeef-2171-e063-6294a90ae506
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide Homosalate Octocrylene
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- Standard Procedure Inc
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-07-22
- Substance
- HOMOSALATE; OCTOCRYLENE; ZINC OXIDE
- Active strength
- 60; 30; 80 mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 84425-105 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 84425-105 | 84425-105-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
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
- Standard Procedure Lip Balm SPF 50
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HOMOSALATE | 60 mg/mL |
| OCTOCRYLENE | 30 mg/mL |
| ZINC OXIDE | 80 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V06SV4M95S | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1e3db995-b1c5-3a2e-e063-6294a90af75e | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84425-105-05 | Standard Procedure Lip Balm SPF 50 | 5 mL in 1 TUBE | STICK | 5 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| MISTINE UV DEFENSE FACE MOISTURIZER SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BETTER INVENTION LTD | 4b9a9303-662f-9614-e063-6294a90a6b51 | 2026-02-24 | Warnings | M020 |
| SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50 | SUNSCREEN | Saltair Body LLC | 4b9ac780-ef7d-42fc-e063-6394a90ad62f | 2026-02-24 | Warnings | M020 |
| PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50 | SUNSCREEN | Saltair Body LLC | 4b9b36a6-4da9-8439-e063-6394a90aa86b | 2026-02-24 | Warnings | M020 |
| SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | Shiseido Americas Corporation | b93f10dc-193d-4cda-94b6-3f0e54d89f21 | 2026-02-23 | Warnings | M020 |
| cle de peau BEAUTE ADVANCED PROTECTIVE DAY | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | 710975d8-43bf-40b9-82c2-d4dc2988956d | 2026-02-23 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR MINERAL | TITANIUM DIOXIDE AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 5e31eee8-6532-47ea-99fc-22418791804b | 2026-02-23 | Warnings | M020 |
| Eryfotona Ageless | ZINC OXIDE | ISDIN Corp. | a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f | 2026-02-23 | Warnings | M020 |
| Perfect Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | SKIN PERFECT MEDICAL | 4b47e7cb-17d6-6a7c-e063-6294a90abbea | 2026-02-20 | Warnings | M020 |
| Beauty Hydrating | HOMOSALATE, ZINC OXIDE | Meijer, Inc. | 69b72139-757f-476d-99d2-33f5524c41d2 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| daily moisturizer | AVBENZONE, OCTISALATE, OCTOCRYLENE | Meijer, Inc. | 6d301146-46e0-445c-b14e-3ec8ce76cb45 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Meijer, Inc. | e9f4a2bb-d21e-4b38-9a37-23c23c8ad857 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| Inkeeze Tattoo Products Hi-Definition Tattoo Sunscreen SPF 50 Coconut Scent | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Ink-eeze | 3f759bec-4e33-46fa-a800-fa3a17d63df9 | 2026-02-19 | Warnings | M020 |
| Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42 | TITANIUM DIOXIDE, ZINC OXIDE | ALLAY SKIN SOLUTIONS LLC | 425bf1d7-f2cf-4237-9047-dd53054acd1c | 2026-02-18 | Warnings | M020 |
| e.l.f. Best and Obsessed Skincare Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 4b1c1150-5ac5-4a8b-e063-6394a90a5410 | 2026-02-18 | Warnings | M020 |
| Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN | TITANIUM DIOXIDE | S.A. COMPTOIR NOUVEAU DE LA PARFUMERIE | dacff3dc-49d7-6416-e053-2a95a90a85c6 | 2026-02-18 | Warnings | M020 |
| Degree Clinical | COOL RUSH INVISIBLE SOLID 96H ANTIPERSPIRANT DEODORANT | Conopco Inc. d/b/a/ Unilever | 4b1f9fd3-3c49-9a98-e063-6294a90a20e0 | 2026-02-18 | Warnings | M020 |
| e.l.f. Wake the E.L.F. Up Skincare Set | AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE | e.l.f. Cosmetics, Inc | 4b20c56a-3e91-3419-e063-6294a90ad361 | 2026-02-18 | Warnings | M020 |
| Dermatone Mineral SPF 30 | ZINC OXIDE 20% | Dermatone Labs LLC | 26e3209f-cb5c-484e-9b2e-74dc397d4790 | 2026-02-18 | Warnings | M020 |
| SHISEIDO ESSENTIAL ENERGY HYDRATING DAY | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | SHISEIDO AMERICAS CORPORATION | 8b88039a-09fe-458b-b80f-49cde49b6595 | 2026-02-17 | Warnings | M020 |
| cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | f3729d0b-e601-48bb-9907-1d6e3ab31996 | 2026-02-17 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84425-105-05 | 84425010505 | 5 mL in 1 TUBE (84425-105-05) | 5 ml | 2024-07-22 | No | No | Current |