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 |
|---|---|---|---|---|---|---|
| UV Defense me. Matte Airy-Fit Sunscreen | ZINC OXIDE | MAGNIF CO., LTD | 459f2b8d-453c-4dee-e063-6394a90a4509 | 2025-12-10 | Warnings | M020 |
| RoC Hydration Plus SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | 45a3e250-8195-344d-e063-6294a90ae681 | 2025-12-10 | Warnings | M020 |
| ROC MULTI CORREXION HYDRATE AND PLUMP DAILY MOISTURISER SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | bf3c1474-e353-63a5-e053-2a95a90a9b26 | 2025-12-10 | Warnings | M020 |
| ROC MULTI CORREXION EVEN TONE LIFT DAILY MOISTURIZER SPF30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | f161d754-0c32-2fbe-e053-2a95a90a6b47 | 2025-12-10 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242ff053-b8c0-4f90-e063-6294a90a7bb3 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORY | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247ef1f8-ad12-4f80-e063-6394a90a3e3c | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | e810d366-0c32-5b1c-e053-2a95a90a622e | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242b7d0e-82d8-793c-e063-6294a90a4aa3 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | eb744367-f318-e1e2-e053-2a95a90a2cc4 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242faaed-e85a-a1d7-e063-6294a90aea92 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247d6c0e-8f88-faf0-e063-6394a90a10da | 2025-12-09 | Warnings | M020 |
| AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | Aekyung Industrial Co., Ltd. | 1e9a5c77-7027-3b52-e063-6394a90ac0eb | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | e8241828-17b2-96c5-e053-2a95a90a12e5 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 1176181b-1331-ba68-e063-6394a90a961a | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247b56ad-4b61-8b6f-e063-6394a90af3b6 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247afcae-855e-3f69-e063-6394a90a4231 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 24306304-4d0d-c5f0-e063-6394a90afad5 | 2025-12-09 | Warnings | M020 |
| AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN TWIN PACK | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | Aekyung Industrial Co., Ltd. | 1f9c7718-6fde-236c-e063-6394a90afa19 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3482855b-de85-a5a7-e063-6294a90a55ae | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3483e7e6-b301-136d-e063-6294a90aba18 | 2025-12-09 | 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 |