Sunscreen
- Product NDC
- 61010-6103
- 11-digit product format
- 610106103
- Labeler code
- 61010
- Product ID
- 61010-6103_10dfe53b-4cdd-c203-e063-6294a90af360
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octinoxate, Octisalate, Oxybenzone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Safetec of America, Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2007-03-13
- Substance
- HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
- Active strength
- 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g
- 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
- Sunscreen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HOMOSALATE | 6 mg/g |
| OCTINOXATE | 7.5 mg/g |
| OCTISALATE | 5 mg/g |
| OXYBENZONE | 5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V06SV4M95S | Internal UNII lookup |
| 4Y5P7MUD51 | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 95OOS7VE0Y | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 754186c8-3c88-40a0-a4e3-35e3ea9d1b4c | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61010-6103-0 | Sunscreen | 3.5 g in 1 PACKET | LOTION | 3.5 | 6 | |
| 61010-6103-1 | Sunscreen | 25 in 1 BOX | LOTION | 25 | 6 | |
| 61010-6103-2 | Sunscreen | 2 g in 1 PACKET | LOTION | 2 | 6 | |
| 61010-6103-3 | Sunscreen | 25 in 1 BOX | LOTION | 25 | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61010-6103 | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240214_754186c8-3c88-40a0-a4e3-35e3ea9d1b4c.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 |
|---|---|---|---|---|---|---|
| Mine Line Coconut Sunscreen SPF 50 | ZINC OXIDE | Spa de Soleil | 4642b1cc-43b1-6997-e063-6394a90ac764 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 30 Broad Spectrum Sunscreen | SPF 30 BROAD SPECTRUM SUNSCREEN | SnugZ/USA, LLC | 69ac1218-76e6-04ff-e053-2a91aa0a4080 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 50 Sunscreen Spry | SPF 50 SUNSCREEN SPRAY | SnugZ USA | 9390ea21-9f9f-14e2-e053-2a95a90ac577 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 15 Flavored Beeswax Lip Balm | SPF 15 FLAVORED BEESWAX LIP BALM | SnugZ/USA, LLC | 69bdfaaf-d49e-bf31-e053-2a91aa0affd3 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 50 Broad Spectrum Sunscreen | SPF 50 BROAD SPECTRUM SUNSCREEN | SnugZ/USA, LLC | b7a3eed5-c8ca-ffda-e053-2a95a90a73bb | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 15 Beeswax Lip Balm | SPF 15 BEESWAX LIP BALM | SnugZ/USA, LLC | 68816d3a-dbe9-7ce3-e053-2a91aa0a395e | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 30 Soy Lip Balm | SPF 30 SOY LIP BALM | SnugZ/USA, LLC | 687ff49d-2d0e-2534-e053-2991aa0a2864 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 50 Sunscreen Stick | SPF 50 SUNSTICK | SnugZ/USA, LLC | 6e1179cf-5bfb-1156-e053-2991aa0a5b46 | 2025-12-29 | Warnings | M020 |
| OUHOE Face Body Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46d36f60-2a5d-816e-e063-6294a90a2ddc | 2025-12-26 | Warnings | M020 |
| OUHOE Bean Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46d3b11f-93d9-0e38-e063-6294a90a41c3 | 2025-12-26 | Warnings | M020 |
| Cream | ZINC OXIDE | MONAT GLOBAL CORP | e922d89c-4232-77d8-e053-2995a90a85e5 | 2025-12-26 | Warnings | M020 |
| Cream | ZINC OXIDE | MONAT GLOBAL CORP | e9231470-9292-0e70-e053-2a95a90a767a | 2025-12-26 | Warnings | M020 |
| Cream | ZINC OXIDE | MONAT GLOBAL CORP | e92288bb-739a-2f73-e053-2995a90ac01f | 2025-12-26 | Warnings | M020 |
| StriVectin-SH NIA-114 UVA UVB Shields SPF 30 | HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONE | StriVectin Operating Company Inc. | 232cbde4-d8ea-4831-9b44-c2e93203260a | 2025-12-26 | Warnings | M020 |
| Cardon | AVOBENZONE, HOMOSALATE, OCTYL SALICYLATE | Cardon, Inc | 72ee2c06-242e-29a2-e053-2991aa0ad8dc | 2025-12-26 | Warnings | M020 |
| OUHOE Water-Permeable Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46e63e1e-7851-ca26-e063-6394a90a9b53 | 2025-12-26 | Warnings | M020 |
| OUHOE Sun Milk | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46e678dd-13c5-b317-e063-6294a90aa989 | 2025-12-26 | Warnings | M020 |
| Dermatone Sport SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6% | Dermatone Labs LLC | 0e60e5bb-b941-4114-933a-29480bff5960 | 2025-12-24 | Warnings | M020 |
| Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Natural | AVOBENZONE, OCTISALATE, OCTINOXATE | Intelligent Elixirs, LLC | 287a61d8-0056-6211-e063-6394a90aa3da | 2025-12-24 | Warnings | M020 |
| Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen for the face | HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452b5997-d229-60ee-e063-6394a90a68db | 2025-12-23 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61010-6103-0 | 61010610300 | 3.5 g in 1 PACKET | 3.5 g | Historical | ||||
| 61010-6103-1 | 61010610301 | 25 PACKET in 1 BOX (61010-6103-1) / 3.5 g in 1 PACKET (61010-6103-0) | 25 packet | 2007-03-13 | 0000-00-00 | No | No | Current |
| 61010-6103-2 | 61010610302 | 2 g in 1 PACKET | 2 g | Historical | ||||
| 61010-6103-3 | 61010610303 | 25 PACKET in 1 BOX (61010-6103-3) / 2 g in 1 PACKET (61010-6103-2) | 25 packet | 2018-07-01 | 0000-00-00 | No | No | Current |