Botnia Gentle Sun SPF 30
- Product NDC
- 87461-904
- 11-digit product format
- 874610904
- Labeler code
- 87461
- Product ID
- 87461-904_4c1e721a-a8f5-db1b-e063-6294a90a0a26
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Botnia, Inc
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-01-19
- Substance
- ZINC OXIDE
- Active strength
- 180 mg/mL
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Botnia Gentle Sun SPF 30
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 180 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 005d0245-fe53-47e5-888b-683f58cd6d26 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87461-904-00 | Botnia Gentle Sun SPF 30 | 50 mL in 1 TUBE | CREAM | 50 | 1 | |
| 87461-904-00 | Botnia Gentle Sun SPF 30 | 1 in 1 BOX | CREAM | 1 | 1 |
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 |
|---|---|---|---|---|---|---|
| Fruit of the Earth Sun Town City Mineral SPF 70 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Fruit Of The Earth, Inc. | f540b0f6-3e6c-43a7-e053-2a95a90aba74 | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth Sun Town City Mineral SPF 30 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Fruit Of The Earth, Inc. | f4481bf3-6dc7-5641-e053-2a95a90ad938 | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth Sun Town City | LIP BALM SPF 30 SUNSCREEN STICK | Fruit of the Earth, Inc. | 3ec16996-ae86-4f5b-b1fd-c7b509cc5d50 | 2024-10-18 | Warnings | M020 |
| Cabana Beach Club with Mentha and Essential Oils SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Fruit of the Earth, Inc. | f452df0c-ea8d-e25c-e053-2995a90a1143 | 2024-10-18 | Warnings | M020 |
| FRUIT OF THE EARTH 100 DRY TOUCH BROAD SPECTRUM SPF 100 FACE SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | FRUIT OF THE EARTH, INC. | fa18f1a9-7a6a-856e-e053-6294a90aeafa | 2024-10-18 | Warnings | M020 |
| Cabana Beach Club with Blood Orange and Essential Oils SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Fruit of the Earth, Inc. | f452f94a-d2f1-60ec-e053-2995a90a8827 | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth Sun Town City Mineral SPF 50 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Fruit Of The Earth, Inc. | f45d25d2-9305-5858-e053-2a95a90a7f7b | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth Sun Town City Mineral SPF 70 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Fruit Of The Earth, Inc. | f53fff7a-ef8b-19c4-e053-2a95a90a4a2a | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Fruit Of The Earth, Inc. | fd68012d-814b-ac07-e053-6394a90afc68 | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | FRUIT OF THE EARTH, INC. | fd687b34-e4c6-0458-e053-6394a90ac064 | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth LUV THAT SUN Kids Sunscreen Ultra SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | FRUIT OF THE EARTH, INC. | fd786a06-88b7-fa35-e053-6394a90a84a5 | 2024-10-18 | Warnings | M020 |
| Chemical Sunscreen SPF50 with Antipollution | HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE SUNSCREEN | Swiss-American CDMO, LLC | 59efb7dd-83f9-4222-9b7e-ea17ac4ece00 | 2024-10-18 | Warnings | M020 |
| CVS Health SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS Pharmacy | f0d6ac48-3d57-0f5c-e053-2a95a90a87cf | 2024-10-17 | Warnings | M020 |
| CVS HEALTH SPORT SPF 50 CLEAR SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f13f7361-56b3-7ea8-e053-2995a90a7641 | 2024-10-17 | Warnings | M020 |
| CVS Health SPF 50 Ultra Protection | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | CVS PHARMACY | f11650bb-90a0-78a1-e053-2995a90a8e4c | 2024-10-17 | Warnings | M020 |
| CVS Health Sport SPF 70 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | f31dd448-dc79-21f1-e053-2a95a90a7bb6 | 2024-10-17 | Warnings | M020 |
| CVS Health SPF 30 Breakout Free Face | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f41478c8-76c0-727f-e053-2a95a90a8669 | 2024-10-17 | Warnings | M020 |
| CVS Health SPF 30 Ultra Protection | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f12ba764-afea-3f81-e053-2a95a90a1291 | 2024-10-17 | Warnings | M020 |
| CVS Health SPF 30 Ultra Sheer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f32ec4ef-352e-6a78-e053-2995a90af491 | 2024-10-17 | Warnings | M020 |
| CVS Health Sport SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f40e5664-e3ca-badf-e053-2a95a90a913e | 2024-10-17 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87461-904-00 | 87461090400 | 1 TUBE in 1 BOX (87461-904-00) / 50 mL in 1 TUBE | 1 tube | 2026-01-19 | No | No | Current |