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
- 2026-12-31
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 |
|---|---|---|---|---|---|---|
| HAWAIIAN TROPIC | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 5990fe66-4fa2-06aa-e063-6294a90a5261 | 2026-08-21 | Warnings | M020 |
| Hawaiian Tropic | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 5991466a-e729-16b7-e063-6394a90a11ff | 2026-08-21 | Warnings | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 597b78df-83cb-1b21-e063-6294a90a56a8 | 2026-08-20 | Warnings, Adverse reactions | M020 |
| Sunski Base Camp Face and Body Sunscreen SPF 45 | HOMOSALATE, OCTISALATE, AVOBENZONE | Stewart Charley Ventures, LLC | 2fc45f85-a6f8-4893-8b34-4db5e39cb615 | 2026-08-20 | Warnings | M020 |
| Sweat Resistant Sunscreen Body Original | TITANIUM DIOXIDE, ZINC OXIDE | Clutch, Inc. | 4bbde755-e312-123e-e063-6294a90a467f | 2026-08-20 | Warnings | M020 |
| Sunscreen | BROAD SPECTRUM SPF 30 | Concierge Choice LLC | 5980055b-493e-4763-e063-6294a90a570f | 2026-08-20 | Warnings | M020 |
| Lip Balm SPF 15 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Skin Script, LLC | 20c5fde7-ee8f-4b74-e063-6394a90a93ec | 2026-08-19 | Warnings | M020 |
| Aloe UP .5OZ SPF 50 MINERAL Sunscreen | ZINC OXIDE 14.69% | Aloe Care International, LLC | 6ad80af3-78cd-4211-a5f2-68531aae264a | 2026-08-19 | Warnings | M020 |
| Utu Broad Spectrum SPF 50 Tinted Sunscreen-Stick | ZINC OXIDE | Utu Co | 596e17d3-3064-1cda-e063-6294a90af963 | 2026-08-19 | Warnings | M020 |
| Mineral sunscreen | MINERAL SUNSCREEN | Guangzhou Origin Beauty Cosmetics Co., Ltd. | 59713657-a7ef-1aee-e063-6394a90a326e | 2026-08-19 | Warnings | M020 |
| The Naked Bee SPF 50 Mineral Sunscreen | ZINC OXIDE 14.69% | The Naked Bee | f820a9be-c94d-4fd5-b202-2dda5746a82a | 2026-08-18 | Warnings | M020 |
| The Naked Bee SPF 50 Mineral Sunscreen | ZINC OXIDE 20% | The Naked Bee | 7dd2b1cd-e229-4eeb-8122-46fde5af1091 | 2026-08-18 | Warnings | M020 |
| Sun Zapper - Baby pure zinc sunscreen SPF30 | ZINC OXIDE SUNSCREEN | VEGANIC SKN LIMITED | 3ee52faa-64a8-4bdf-e063-6294a90a65cf | 2026-08-17 | Warnings | M020 |
| Sun Zapper - Face pure zinc sunscreen SPF30 | ZINC OXIDE SUNSCREEN | VEGANIC SKN LIMITED | 3ee4feb3-6966-67f9-e063-6394a90a16d5 | 2026-08-17 | Warnings | M020 |
| HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN | ZINC OXIDE,TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 4339df13-77d3-31a1-e063-6394a90a5208 | 2026-08-17 | Warnings | M020 |
| Soleil Defense Sunscreen | BROAD SPECTRUM SPF 30 | AMARA MED SPA LLC | 594244b1-db3b-002b-e063-6394a90a0329 | 2026-08-17 | Warnings | M020 |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | HAMBLIN DERMATOLOGY | 5942e64c-416e-7525-e063-6394a90a2839 | 2026-08-17 | Warnings | M020 |
| Protect Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | Opal Day Spa | 5943413a-48e1-0bdf-e063-6294a90a2fff | 2026-08-17 | Warnings | M020 |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | MedSpa By Beauty Bar LLC | 5943ba3d-688e-9e9c-e063-6294a90afa9a | 2026-08-17 | Warnings | M020 |
| Sunscreen | BROAD SPECTRUM SPF 30 | Charleston Dermatology, P.C. | 59440f7f-4213-6e2b-e063-6394a90af483 | 2026-08-17 | 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 |