Zinc Oxide 20%
- Product NDC
- 69630-004
- 11-digit product format
- 696300004
- Labeler code
- 69630
- Product ID
- 69630-004_4db2b8a1-b627-9f7b-e063-6394a90a1fa9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sunscreen SPF 50
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- The Soleil Group, LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-09
- Substance
- ZINC OXIDE
- Active strength
- 20 g/100mL
- 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
- Zinc Oxide 20%
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 20 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 27d20573-0b6b-4d4b-94ca-69b476a883a7 | 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 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69630-004-01 | Zinc Oxide 20% | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 69630-004-01 | Zinc Oxide 20% | 16 mL in 1 BOTTLE | LOTION | 16 | 2 |
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 |
|---|---|---|---|---|---|---|
| HAWAIIAN TROPIC | AVOBENZONE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 053e76f0-8ca0-645d-e063-6394a90a01d2 | 2025-09-28 | Warnings | M020 |
| Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30 | ZINC OXIDE | Edgewell Personal Care Brands LLC | cdc54f23-0efb-2fb4-e053-2995a90ae58b | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 0540017a-52ac-7972-e063-6394a90a139c | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 08f3b27f-b233-d406-e063-6394a90ada76 | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 128a3772-b9b7-0d10-e063-6294a90a3e05 | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 203c82a2-0131-8023-e063-6294a90aba7b | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 203c780a-3107-d71a-e063-6394a90aca25 | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 31d01fae-4085-d84a-e063-6294a90ab981 | 2025-09-28 | Warnings | M020 |
| Hawaiian Tropic | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands, LLC | 3388c2fa-8082-95d4-e063-6294a90a94b8 | 2025-09-28 | Warnings | M020 |
| Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | Kenvue Brands LLC | b10a7794-7e4f-412b-9eb2-773107ecb7fc | 2025-09-26 | Warnings | M020 |
| Black Girl Sunscreen SPF 50 | HOMOSALATE 10.00% OCTOCRYLENE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00% | Black Girl Sunscreen | fed22570-e0ae-43e1-b6ce-1f0ad01684c3 | 2025-09-26 | Warnings | M020 |
| Smooth Even Glow | TINTED SUNSCREEN BROAD SPF30 | SKNVcare, LLC | 3fa48151-fcb9-3d35-e063-6394a90a2eb6 | 2025-09-25 | Warnings | M020 |
| CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVE | AVOBENZONE, HOMOSALATE, OCTISALATE | MDSolarSciences | 3fa810b0-0211-f2a7-e063-6294a90a0b72 | 2025-09-25 | Warnings | M020 |
| SUN BUFF SPF 30 MINERAL SUNSCREEN | ZINC OXIDE/TITANIUM DIOXIDE | SPF Ventures, LLC | 3f874062-ebab-8993-e063-6294a90abfc5 | 2025-09-24 | Warnings | M020 |
| HygieneLab Face and Body Mineral Sunscreen SPF 50 | ZINC OXIDE | HYGIENELAB, INC | 7db103da-b434-433a-a18f-a727165640c0 | 2025-09-24 | Warnings | M020 |
| Eve Lom Daily Protection Broad Spectrum SPF 50 Sunscreen | HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENE | Space Brands Limited | 0e2c9ffb-036d-49c5-abdb-2ee8888df318 | 2025-09-24 | Warnings | M020 |
| PUR 4-in-1 Skin Tint DG6 | ZINC OXIDE | PUR Minerals | 3f8e97a7-2023-ba9c-e063-6294a90ac9c9 | 2025-09-24 | Warnings | M020 |
| PUR 4-in-1 Skin Tint TN7 | ZINC OXIDE | PUR Minerals | 3f0717c7-f43f-e3b1-e063-6394a90a74dd | 2025-09-24 | Warnings | M020 |
| PUR 4-in-1 Skin Tint TN2 | ZINC OXIDE | PUR Minerals | 3f06ed2f-f43f-53d4-e063-6294a90af0dd | 2025-09-24 | Warnings | M020 |
| PUR 4-in-1 Skin Tint MN4 | ZINC OXIDE | PUR Minerals | 3f06f618-f7b2-53d0-e063-6294a90a829c | 2025-09-24 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69630-004-01 | 69630000401 | 1 BOTTLE in 1 CARTON (69630-004-01) / 16 mL in 1 BOTTLE | 1 bottle | 2025-12-01 | No | No | Current |