COOLA Classic Body Sunscreen Fragrance-Free
- Product NDC
- 54111-145
- 11-digit product format
- 541110145
- Labeler code
- 54111
- Product ID
- 54111-145_5368324e-9b83-48dc-8ab3-88146d9423f8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Bentley Laboratories, LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-11-06
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 1.75; 5; 2; 5 g/100mL; g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 54111-145-51 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 54111-145-51 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 54111-145-51 | bd6a592717d7… | 303034d00443… |
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
- COOLA Classic Body Sunscreen Fragrance-Free
- Brand name suffix
- SPF 50
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AVOBENZONE | 1.75 g/100mL |
| HOMOSALATE | 5 g/100mL |
| OCTISALATE | 2 g/100mL |
| OCTOCRYLENE | 5 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G63QQF2NOX | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 57f2fdeb-2abc-4ad3-bb89-5faee883c0e5 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54111-145-51 | 2023-01-06 | C162847 | 48780-1 | d6a99b39-6d3f-a426-e053-dadaa90af4c2 | COOLA CLASSIC BODY SUNSCREEN Fragrance-Free SPF 50 |
| 54111-145-51 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6d3f-a426-e053-dadaa90af4c2 | COOLA CLASSIC BODY SUNSCREEN Fragrance-Free SPF 50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54111-145-51 | COOLA Classic Body Sunscreen Fragrance-FreeSPF 50 | 148 mL in 1 TUBE | LOTION | 148 | 6 | |
| 54111-145-51 | COOLA Classic Body Sunscreen Fragrance-FreeSPF 50 | 1 in 1 BOX | LOTION | 1 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54111-145 | COOLA CLASSIC BODY SUNSCREEN FRAGRANCE-FREE SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [BENTLEY LABORATORIES, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20231221_57f2fdeb-2abc-4ad3-bb89-5faee883c0e5.zip |
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 |
|---|---|---|---|---|---|---|
| Sunscreen SPF 50 | SUNSCREEN SPF 50 | Guangzhou Ariel Biotech Co., Ltd. | 14b9ec0e-6fff-44b1-e063-6394a90aab97 | 2026-03-05 | Warnings | M020 |
| belif Aqua bomb - glow sunstick SPF50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | LG H&H CO., LTD. | 4c35fbbc-a79d-318f-e063-6394a90a30a7 | 2026-03-04 | Warnings | M020 |
| Kids Mineral Sunscreen Stick SPF 50 | ZINC OXIDE | Smalls Brand LLC DBA Roe Wellness | 4c37855b-08c0-0aa7-e063-6394a90a8842 | 2026-03-04 | Warnings | M020 |
| La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE | LOreal USA Products Inc | be03b588-afbd-41d1-be96-444d735c9768 | 2026-03-03 | Warnings | M020 |
| UNME SOULMA CENTELLA and BEEF TALLOW SUNSCREEN | ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, ZINC OXIDE, PHENYLBENZIMIDAZOLE SULFONIC ACID | Shenzhen Jufeng Qiyuan Trading Co., Ltd. | 4c1a3345-58c1-93c8-e063-6394a90a865e | 2026-03-03 | Warnings | M020 |
| Botnia Gentle Sun SPF 30 | ZINC OXIDE | Botnia, Inc | 005d0245-fe53-47e5-888b-683f58cd6d26 | 2026-03-03 | Warnings | M020 |
| Broad Spectrum Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 64534ec3-396c-4c11-9ec1-e2615f7e24b1 | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 9b7249e4-4c1f-40e7-a657-d40c53d9317f | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Sunscreen | SUNSCREEN | Old East Main Co. | 1673b8b1-08ad-40a5-8180-93333a8edb67 | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 32036e41-2414-4498-8e1c-61511abf7a32 | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 100 | AVOBENZONE HOMOSALATE OCTISALATE | Old East Main Co. | 42266fa5-5f30-2a9f-e063-6394a90a1dfe | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Amazon.com Services LLC | d4b4ebac-c6c2-474b-afc6-b80b8431e90f | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Fruit Snack SPF 15 Broad Spectrum Lip Balm | FRUIT SNACK SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | 24c2a9fc-892b-c74d-e063-6394a90af62c | 2026-03-03 | Warnings | M020 |
| Olay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 4c231aa1-75eb-c171-e063-6294a90a8b8b | 2026-03-03 | Warnings | M020 |
| SPF 30 Mineral Sunscreen | ZINC OXIDE | Smalls Brand LLC DBA Roe Wellness | 4c25b4ec-b045-7066-e063-6294a90ab801 | 2026-03-03 | Warnings | M020 |
| Good Weather Skin Daily Lip Sun Gloss SPF 30 Iced Coffee | ZINC OXIDE | Good Weather Inc. | 4c261e88-7f37-2361-e063-6294a90aa602 | 2026-03-03 | Warnings | M020 |
| Good Weather Skin All Over Sun Milk Face and Body SPF 50 | ZINC OXIDE | Good Weather Inc. | 4c278acc-7cd5-0d85-e063-6394a90a3a72 | 2026-03-03 | Warnings | M020 |
| Lekura - ZincDaily Natural Face Sunscreen SPF50 | ZINC OXIDE SUNSCREEN | VEGANIC SKN LIMITED | 4c2bed23-f77b-2c97-e063-6394a90a4ca5 | 2026-03-03 | Warnings | M020 |
| NEOGEN DERMALOGY DAY-LIGHT PROTECTION AIRY SUNSCREEN BROAD SPECTRUM SPF 50 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | OUTIN FUTURES CO.,LTD. | 4ddce1f0-44a3-7e0c-e063-6294a90a3f7d | 2026-03-03 | Warnings | M020 |
| Bephor Reviving Suncream SPF50 | ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, ZINC OXIDE | Gyeongbuk Institute of IT Convergence Industry Technology | 4c055b22-94e9-ff0d-e063-6394a90ab2ec | 2026-03-02 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54111-145-51 | 54111014551 | 1 TUBE in 1 BOX (54111-145-51) / 148 mL in 1 TUBE | 1 tube | 2019-11-06 | 2023-12-31 | No | No | Current |