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 |
|---|---|---|---|---|---|---|
| Tanning Club Mineral Sunscreen SPF 30 | ZINC OXIDE | Tanning Club LLC | d674ccbc-7bae-435c-a531-a79e569e69a9 | 2026-02-04 | Warnings | M020 |
| Derma B Everyday Fit Sunscreen SPF 50 | AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | NeoPharm Co., Ltd. | ba38a43d-7a8a-4814-ba34-0e99124f5fca | 2026-02-04 | Warnings | M020 |
| SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42 | TITANIUM DIOXIDE AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 86630e82-f249-4866-82dd-3e21feb266c4 | 2026-02-04 | Warnings | M020 |
| SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 42adc51f-f500-485d-82a0-126672141262 | 2026-02-04 | Warnings | M020 |
| SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 60e55ebb-47b8-465e-819a-af195952e1ca | 2026-02-04 | Warnings | M020 |
| SHISEIDO BENEFIANCE NUTRIPERFECT DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | f644c67b-3a71-411b-b321-39a8b18af0c7 | 2026-02-04 | Warnings | M020 |
| cle de peau BEAUTE UV PROTECTIVE N | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | 4b242b76-8aed-4939-9906-741828acd815 | 2026-02-04 | Warnings | M020 |
| cle de peau BEAUTE PORE-REFINING MATTIFYING VEIL | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | efcf240f-95cb-45e0-b58a-9c8f3609aa55 | 2026-02-04 | Warnings | M020 |
| cle de peau BEAUTE PORE-REFINING MATTIFYING VEIL | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | 270ecc83-4262-4102-a753-2acaf11360a0 | 2026-02-04 | Warnings | M020 |
| Walgreens 50 Caramel and Pistachio Scented Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WALGREEN COMPANY | 4a038017-9f15-b4b2-e063-6294a90a1b23 | 2026-02-04 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR | OCTISALATE, OCTOCRYLENE, ZINC OXIDE | Shiseido Americas Corporation | ce6a28c1-56e6-4105-bc9d-9d1986ead420 | 2026-02-04 | Warnings | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | HARRIS TEETER | d52e2c61-edbc-4c26-b1a7-e8eb656db188 | 2026-02-04 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | HARRIS TEETER | d365ed6d-a92f-473b-be19-b8b63d17f3b7 | 2026-02-04 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | HARRIS TEETER | 0a3b4597-06fe-4689-9751-6577867d755e | 2026-02-04 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | HARRIS TEETER | b83ea476-fa32-4405-9ae3-f294836edb62 | 2026-02-04 | Warnings | M020 |
| Sunplus SPF50 Face Body Sunscreen | SUNSCREEN | I.Shay Cosmetics | 26d55baf-66dc-b1b8-e063-6394a90a670d | 2026-02-04 | Warnings | M020 |
| NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Angel Glow | ZINC OXIDE SUNSCREEN | Bentley Laboratories, LLC | 351217c4-8d71-41d9-ab08-c43857c0510c | 2026-02-04 | Warnings | M020 |
| NIDA Invisible Fit Sun Stick | SUN STICK | Proso Corp | 49eca4f2-aae3-a0d5-e063-6394a90ab25f | 2026-02-03 | Warnings | M020 |
| Shiny Hiny SPF 45 Mineral Sunscreen | ZINC OXIDE | Shiny Hiny Products, LLC | 31adde36-5e1b-40ff-e063-6294a90a6f2e | 2026-02-03 | Warnings | M020 |
| Walgreens 50 Passion Fruit Scented Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WALGREEN COMPANY | 49f030d8-959c-a3cd-e063-6294a90ae1ba | 2026-02-03 | 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 |