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 |
|---|---|---|---|---|---|---|
| Drs. pharmacy sunscreen SPF 50 (physical filters) | SUNSCREEN SPF 50 | OL PHARMA TECH LLC. (Drs. Pharmacy) | 315a5ca4-4536-d585-e063-6294a90a1c50 | 2026-01-06 | Warnings | M020 |
| Drs. pharmacy sunscreen SPF 30 (Physical Filters) | SUNSCREEN SPF 30 | OL PHARMA TECH LLC. (Drs. Pharmacy) | 315a5b1f-9dc2-a243-e063-6394a90a5e08 | 2026-01-06 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 51f759b7-8c49-41d4-aaa3-f901d599cac5 | 2026-01-06 | Warnings | M020 |
| cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill) | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 463dc557-9743-4a38-969e-2c78fc10ee2a | 2026-01-06 | Warnings | M020 |
| CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 23bb4225-bfb5-47e2-80fe-733761ba4069 | 2026-01-06 | Warnings | M020 |
| SHISEIDO WHITE LUCENT DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | e881e637-e0f0-4c90-8343-2be6e74020b8 | 2026-01-06 | Warnings | M020 |
| Hawaiian Tropic Lip Balm Sunscreen SPF 30 | AVOBENZONE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | c7b71be3-f906-bd09-e053-2995a90adc61 | 2026-01-06 | Warnings | M020 |
| SHISEIDO BENEFIANCE WRINKLERESIST24 DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | d308d578-c881-4c10-8c79-9e3cd58b694c | 2026-01-06 | Warnings | M020 |
| Coppertone Sport Sunscreen Lip Balm SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | Beiersdorf Inc | 47bc6776-1130-0162-e063-6294a90a2adc | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 088fa3cd-b9b8-d10b-e063-6394a90a7fd6 | 2026-01-06 | Warnings | M020 |
| SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body Oil | HOMOSALATE, OCTISALATE, OCTOCRYLENE | Naples Soap Company, Inc. | 47c147a9-c4f4-ab82-e063-6394a90aaa5c | 2026-01-06 | Warnings | M020 |
| PoutScreen Lip Treatment Love Letter | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | NAKED SUNDAYS PTY LTD | 47d22c6d-49fd-f97c-e063-6294a90a6ba1 | 2026-01-06 | Warnings | M020 |
| Moisturizing Antioxidant SPF 50 | OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDE | Topiderm, Inc. | 727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f | 2026-01-05 | Warnings | M020 |
| EVERYRAY SUNCARE SUNSHINE SERUM | EVERYRAY SUNCARE SUNSHINE SERUM | Guangzhou Fantesy Biotechnology Co.,Ltd | 062be336-2af4-10e2-e063-6294a90a480a | 2026-01-05 | Warnings | M020 |
| sunscreen powder | SUNSCREEN POWDER | Guangzhou Fantesy Biotechnology Co.,Ltd | fae8ecaf-7a9c-902b-e053-6394a90a5f31 | 2026-01-05 | Warnings | M020 |
| ORLASKIN HYDRATING SUNSCREEN | ORLASKIN HYDRATING SUNSCREEN | Guangzhou Fantesy Biotechnology Co.,Ltd | 0808b0cd-2cfb-8554-e063-6294a90ad6c4 | 2026-01-05 | Warnings | M020 |
| DALLAS JAMES SKINCARE CO. SPF 50 Sunscreen | DALLAS JAMES SKINCARE CO. SPF 50 SUNSCREEN | Guangzhou Fantesy Biotechnology Co.,Ltd | 225faeec-4f96-e082-e063-6394a90a9a31 | 2026-01-05 | Warnings | M020 |
| LING NEW YORK Save Face Broad Spectrum SPF 30 | LING NEW YORK SAVE FACE BROAD SPECTRUM SPF 30 | Guangzhou Fantesy Biotechnology Co.,Ltd | 1dfa80bd-495a-18fb-e063-6394a90a4d0d | 2026-01-05 | Warnings | M020 |
| Sky and Sol Sunscreen SPF30 | SKY AND SOL SUNSCREEN SPF30 | Guangzhou Fantesy Biotechnology Co.,Ltd | 1d917329-dea2-e792-e063-6294a90a0a0d | 2026-01-05 | Warnings | M020 |
| Sky and Sol Sunscreen SPF50 | SKY AND SOL SUNSCREEN SPF50 | Guangzhou Fantesy Biotechnology Co.,Ltd | 1c699b06-c156-b0da-e063-6294a90a947d | 2026-01-05 | 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 |