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 |
|---|---|---|---|---|---|---|
| MEDICUBE PDRN SILKY SUNSCREEN | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | APR US INC | 57154bec-6714-0314-e063-6294a90a4bd0 | 2026-07-20 | Warnings | M020 |
| TOCOBO Double UV Defense Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | PICTON Co., Ltd. | 56aff65a-aa08-dc3f-e063-6294a90acac3 | 2026-07-19 | Warnings | M020 |
| THE SPORTO Invisible Sport for Body | AVOBENZONE, OCTISALATE, AND OCTOCRYLENE | Dune Suncare, Inc. | 46564a09-909d-bcc7-e063-6294a90a627b | 2026-07-17 | Warnings | M020 |
| RR Sun Creme | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Undefined Inc | dc60b685-a7fc-47bb-ade9-44a8e3b54812 | 2026-07-17 | Warnings | M020 |
| Cetaphil Tinted Daily Facial Moisturizer SPF 50 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Galderma Laboratories, L.P. | 0ef2ebae-7198-47f4-8891-d1ca3cf54d4b | 2026-07-16 | Warnings | M020 |
| Mederma Scar Cream | AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE | PMI Branded Pharmaceuticals, Inc. | f9be5adb-dce3-4b17-939f-d80d486f2cb0 | 2026-07-16 | Warnings | M020 |
| BaseLife Pure Mineral Shield Sunscreen | ZINC OXIDE | Wintech America, Inc. | 7f741a91-6ed8-4d08-9196-d15527d044d5 | 2026-07-15 | Warnings | M020 |
| BaseLife Clear UV Defense Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Wintech America, Inc. | 128db446-93ba-4347-bd39-66177572c659 | 2026-07-15 | Warnings | M020 |
| Biore Aqua Rich Facial Mist SPF 50 | OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE | Kao USA Inc. | 56a80a0d-b0b5-1098-e063-6294a90a5270 | 2026-07-15 | Warnings | M020 |
| Anti Aging Lip Balm Pot SPF 15 | LIP BALM | Epicuren Disocovery | 4097e28a-ed11-e16a-e063-6294a90a5e9b | 2026-07-14 | Warnings | M020 |
| HolyCow Mineral Tallow Sunscreen Face and Body SPF 50 | ZINC OXIDE | CALM ENTERPRISE LLC | 722462d8-d2ab-44ce-9065-673ab2076269 | 2026-07-14 | Warnings | M020 |
| X-Treme Cream Propolis Sunscreen SPF 45 | X-TREME CREAM | Epicuren Discovery | 3b29976e-eee0-b978-e063-6294a90accd6 | 2026-07-14 | Warnings | M020 |
| Anti-Aging Lip Balm SPF 15 | LIP BALM | Epicuren Discovery | 3cbd0550-b6e5-3e86-e063-6394a90ac07f | 2026-07-14 | Warnings | M020 |
| Zinc Oxide Perfecting Sunscreen | ZINC OXIDE | Epicuren Discovery | 1a0228f9-bf3f-a1fe-e063-6294a90a3fb5 | 2026-07-14 | Warnings | M020 |
| Vacation Face | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Vacation INC. | 14b8a3cf-031c-4c52-ba81-e683e69d0f37 | 2026-07-14 | Warnings | M020 |
| Mederma Scar Cream | AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE | L. Perrigo Company | bd5c9df7-8dfb-4d20-9966-e148c5667b22 | 2026-07-14 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 4081a4ad-b738-5fb6-e063-6394a90a9171 | 2026-07-13 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 3cc5c1d8-91f8-8ad2-e063-6294a90a9229 | 2026-07-13 | Warnings | M020 |
| Olay Super Serum Body Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 5513c5e2-3baf-2f09-e063-6394a90a495a | 2026-07-13 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 3cc48592-f70d-664e-e063-6294a90ac6e8 | 2026-07-13 | 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 |