CLE CCC Golden Medium
- Product NDC
- 69231-034
- 11-digit product format
- 692310034
- Labeler code
- 69231
- Product ID
- 69231-034_29aa4543-0fcc-c9f5-e063-6294a90a3acc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Octinoxate, Octisalate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- KW ABSC, INC.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-10-25
- Substance
- OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
- Active strength
- 2.1; .9; 2.751 mg/30mL; mg/30mL; mg/30mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- CLE CCC Golden Medium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 2.1 mg/30mL |
| OCTISALATE | .9 mg/30mL |
| TITANIUM DIOXIDE | 2.751 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| de50e956-a014-4147-922b-63c95fa6f86b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d676a241-be05-4740-b3ee-1a5f2ed422d2 | Product name | 4 | 20180615 |
| dd8bd48f-20d6-43c7-b471-3ae872868afa | Product name | 3 | 20180125 |
| d41954ff-bc63-4b2c-aba0-9146707659d7 | Product name | 2 | 20151117 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69231-034-01 | CLE CCC Golden Medium | 30 mL in 1 CONTAINER | CREAM | 30 | 2 | |
| 69231-034-02 | CLE CCC Golden Medium | 1 in 1 PACKAGE | CREAM | 1 | 2 |
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 |
|---|---|---|---|---|---|---|
| Intensive Age Defying Hydrating Complex SPF 25 | HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE | June Jacobs Labs, LLC | 18f59d9d-1328-d815-e063-6294a90a3801 | 2024-05-21 | Warnings | M020 |
| Advanced Sun Resistance SPF 30 | HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE | June Jacobs Labs, LLC | 18f879f0-3d5b-0067-e063-6394a90a9db3 | 2024-05-21 | Warnings | M020 |
| Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | June Jacobs Labs LLC | 18e1edd9-e39b-c91f-e063-6394a90a32a0 | 2024-05-20 | Warnings | M020 |
| Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | June Jacobs Labs, LLC | 18e4c50d-eb91-c269-e063-6394a90a7999 | 2024-05-20 | Warnings | M020 |
| Broad Spectrum SPF 30 Tropical Sunscreen | BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN | Raining Rose, Inc | 18e7fc6b-b40a-f790-e063-6294a90ad0f4 | 2024-05-20 | Warnings | M020 |
| Protectif Untinted | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 18aa2604-c8f0-ca04-e063-6294a90a1c25 | 2024-05-17 | Warnings | M020 |
| Vacation Shimmer Oil | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | Vacation Inc | 150cbb23-fcb9-ed6f-e063-6394a90a597c | 2024-05-16 | Warnings | M020 |
| Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50 | ZINC OXIDE | Babo Botanicals, Inc. | d66dfcec-ad40-3a0b-e053-2995a90aa006 | 2024-05-14 | Warnings | M020 |
| Babo Botanicals Daily Sheer Fluid Mineral Sunscreen SPF 50 | ZINC OXIDE | Babo Botanicals, Inc. | d66c88a1-7684-1043-e053-2a95a90aa2aa | 2024-05-14 | Warnings | M020 |
| Jack Black | TITANIUM DIOXIDE, ZINC OXIDE | Jack Black L.L.C | 181d5bf3-ce91-cb2c-e063-6294a90a51c4 | 2024-05-10 | Warnings | M020 |
| Protectif Fair Tint | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 181e3f34-c5b2-0976-e063-6394a90a9a78 | 2024-05-10 | Warnings | M020 |
| SABIYA Broad Spectrum SPF-30 | ZINC OXIDE | SABIYA, LLC | bc403672-7576-49a6-9a29-4f6cb19af7a4 | 2024-05-09 | Warnings | M020 |
| SABIYA Broad Spectrum SPF-50 | ZINC OXIDE | SABIYA, LLC | 4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c | 2024-05-09 | Warnings | M020 |
| Protectif Deep Tint | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 180b2939-5ae4-88fb-e063-6394a90aad93 | 2024-05-09 | Warnings | M020 |
| UV Daily Deep Tint | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc. | c12fa9a4-d7e5-46bf-9bfb-1cbbaa73b450 | 2024-05-09 | Warnings | M020 |
| Chemical Sunscreen SPF50 | OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREEN | Swiss-American CDMO, LLC | 50f47495-93aa-4e11-a153-d4c847a36c99 | 2024-05-08 | Warnings | M020 |
| UV Clear Deep Tint | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc. | ead07d51-9400-4f0a-8966-7052dfae67bc | 2024-05-08 | Warnings | M020 |
| Essence Pout Protector SPF 20 Lip Balm | HOMOSALATE, OCTISALATE, ZINC OXIDE | cosnova GmbH | 17e483c5-6e47-9a50-e063-6394a90aa604 | 2024-05-07 | Warnings, Adverse reactions | M020 |
| MIRABELLA Broad Spectrum SPF 30 Sunscreen | HOMOSALATE, OCTISALATE, AVOBENZONE | GDM ENTERPRISES LLC | 3ac847d5-a75d-4b32-84e1-70e4282c0d72 | 2024-05-06 | Warnings | M020 |
| MELAN SPF-30 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE | MELAN INC. | 75fcef12-bc33-44a7-acda-77d5d7bca2bc | 2024-05-02 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69231-034-01 | 69231003401 | 30 mL in 1 CONTAINER | 30 ml | Historical | ||||
| 69231-034-02 | 69231003402 | 1 CONTAINER in 1 PACKAGE (69231-034-02) / 30 mL in 1 CONTAINER (69231-034-01) | 1 container | 2022-10-25 | 0000-00-00 | No | No | Current |