FRE PROTECT BODY Ultra-Light Gel Cream SPF 50
- Product NDC
- 69435-1412
- 11-digit product format
- 694351412
- Labeler code
- 69435
- Product ID
- 69435-1412_2ce7cd35-c5f0-c731-e063-6294a90a19c8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE
- Dosage form
- JELLY
- Route
- TOPICAL
- Labeler
- Peer Pharm Ltd.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-14
- Substance
- ZINC OXIDE
- Active strength
- 24 g/100mL
- 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
- FRE PROTECT BODY Ultra-Light Gel Cream SPF 50
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 24 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2cd83c55-851c-089e-e063-6294a90ad6bc | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69435-1412-1 | FRE PROTECT BODY Ultra-Light Gel Cream SPF 50 | 100 mL in 1 BOTTLE, PUMP | JELLY | 100 | 2 | |
| 69435-1412-1 | FRE PROTECT BODY Ultra-Light Gel Cream SPF 50 | 1 in 1 CARTON | JELLY | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69435-1412 | FRE PROTECT BODY ULTRA-LIGHT GEL CREAM SPF 50 (ZINC OXIDE) JELLY [PEER PHARM LTD.] | 2 | Current NDC, 2 package rows | 20250131_2cd83c55-851c-089e-e063-6294a90ad6bc.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 |
|---|---|---|---|---|---|---|
| Coppertone Kids Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 240dd76a-8f39-caec-e063-6294a90abbbc | 2025-12-31 | Warnings | M020 |
| Coppertone Protect and Tan SPF 30 | AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d3994886-2ebe-a9d2-e053-2995a90aaf9a | 2025-12-31 | Warnings | M020 |
| Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d3d471b8-7430-98b0-e053-2995a90aba4b | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 241f78be-0d7f-c5ca-e063-6294a90a997a | 2025-12-31 | Warnings | M020 |
| Coppertone Protect and Tan Sunscreen SPF 45 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdort Inc | d39a009d-1f33-88bb-e053-2a95a90a03a0 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d460d669-42df-46c0-e053-2a95a90ad77b | 2025-12-31 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 8 | AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% | Beiersdorf Inc | d370094c-3373-594b-e053-2a95a90a114a | 2025-12-31 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 15 | (TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | 0a5a35be-9e24-18dd-e063-6394a90a097f | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | d462081f-f082-5df2-e053-2995a90aa1d9 | 2025-12-31 | Warnings | M020 |
| Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d3e66496-bc3c-d189-e053-2a95a90a06b6 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc. | c05388dc-4282-ee79-e053-2a95a90a376a | 2025-12-31 | Warnings | M020 |
| Coppertone Glow Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | b60dcbd1-42d0-646f-e053-2a95a90a497d | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | d474fea9-65a7-672b-e053-2a95a90ab989 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 40 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | d4d9ad73-6394-2391-e053-2a95a90a2df6 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 100 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6% | Beiersdorf Inc | df498e82-e1c9-51eb-e053-2a95a90a49b6 | 2025-12-31 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 15 | AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% | Beiersdorf Inc | d3984138-763b-1002-e053-2995a90acefc | 2025-12-31 | Warnings | M020 |
| Coppertone Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8% | Beiersdorf Inc | d8b0d5ad-a82c-5304-e053-2a95a90afa63 | 2025-12-31 | Warnings | M020 |
| Coppertone Pure and Simple Sunscreen SPF 50 | ZINC OXIDE 24.08% | Beiersdorf Inc | d8d80a15-8282-a18e-e053-2a95a90a2c6c | 2025-12-31 | Warnings | M020 |
| Coppertone Waterbabies Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d915cb28-2813-5a38-e053-2a95a90a45c6 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 15 | AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d46052d3-6f45-5f4d-e053-2995a90a8760 | 2025-12-31 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 69435-1412-1 | 69435141201 | 1 BOTTLE, PUMP in 1 CARTON (69435-1412-1) / 100 mL in 1 BOTTLE, PUMP | 2025-01-14 | No | No | Current |