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 |
|---|---|---|---|---|---|---|
| ROE WELLNESS SPF 50 MINERAL | SPF 50 MINERAL POWDER | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47dc8155-4abb-4bb7-e063-6294a90af1ad | 2026-01-08 | Warnings | M020 |
| ALOHA MINERAL BLOCK-BRUSH ON MINERAL | SUNSCREEN SPF50 | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47dd07aa-71b4-5d54-e063-6394a90a4127 | 2026-01-08 | Warnings | M020 |
| SUNSCREEN SETTING SPRITZ, SPF 45 | SUNSCREEN SETTING SPRAY | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47ddf752-cae2-313f-e063-6294a90a7e3a | 2026-01-08 | Warnings | M020 |
| St Moriz suncare face sunscreen spf50 | OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATE | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47df072e-151f-eb30-e063-6294a90a4eeb | 2026-01-08 | Warnings | M020 |
| SUNSCREEN GLOWING | AVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATE | Aopline Biotechnology (Guangzhou) Co., Ltd. | 47df0de5-012a-c896-e063-6394a90a9cef | 2026-01-08 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 616d35f6-63d2-3d26-e053-2991aa0a5b44 | 2026-01-08 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 616d35a1-a139-1974-e053-2a91aa0a20b6 | 2026-01-08 | Warnings | M020 |
| PIPA SKIN CARE SUN-SATIONAL Mineral Sunscreen | SPF 30 | EVI LABS | 258b7b7c-a3f2-172c-e063-6394a90aec6a | 2026-01-08 | Warnings | M020 |
| DMK Ultrascreen Mineral Sunscreen | ZINC OXIDE | Danne Montague King | 3f022275-c1e5-2704-e063-6294a90a4a81 | 2026-01-08 | Warnings | M020 |
| Anhydrous SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | Owen Biosciences, Inc. | 0cc8221d-5ec5-4abf-a4f5-ab06e8dcea68 | 2026-01-08 | Warnings | M020 |
| Rejuvaskin Mineral Facial Sunscreen SPF 32 Sheer | REJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEER | Atlantic Medical Products, LLC | 47e5198e-7bf6-72a8-e063-6294a90a7ec5 | 2026-01-08 | Warnings | M020 |
| inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUM | INDE WILD SUN DEFENSE GLOW DROPS | INDE WILD PRIVATE LIMITED | 47e57407-2925-09ca-e063-6294a90a49ec | 2026-01-08 | Warnings | M020 |
| NIDA Invisible Fit Sunscreen | SUNSCREEN | Proso Corp | 47ed3b62-45ef-b67a-e063-6294a90a317b | 2026-01-08 | Warnings | M020 |
| Organic Matters SPF 50 Sunscreen | ZINC OXIDE | Veganic SKN Limited | 12f37c8d-07f0-3e75-e063-6294a90a2cdf | 2026-01-08 | Warnings | M020 |
| Ellegreen Sunscreen Broad Spectrum SPF50 | ZINC OXIDE | Veganic SKN Limited | 161a7209-10d8-928c-e063-6394a90a4139 | 2026-01-08 | Warnings | M020 |
| Live Sunny Eco-zinc hydrating mineral sunscreen for body and face | ZINC OXIDE | Veganic SKN Limited | 1a97169e-67be-3d25-e063-6294a90a3b88 | 2026-01-08 | Warnings | M020 |
| Dr Loretta Universal Glow Daily Defense SPF 40 | ZINC OXIDE | Dr. Loretta, LLC | 1208d0f8-bb12-4574-b70e-3a76b11a64c7 | 2026-01-07 | Warnings | M020 |
| Neutrogena Ultra Sheer Face Sunscreen SPF 60 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | KDC/One Development Corporation, Inc. | 259f3fe3-2967-6c05-e063-6394a90a9e45 | 2026-01-07 | Warnings | M020 |
| Hawaiian Blend Extreme Zinc SPF 30 | ZINC OXIDE, TITANIUM DIOXIDE | The Islander Group | 4084dd98-357f-4011-b0d4-db6536d2931f | 2026-01-07 | Warnings | M020 |
| Hawaiian Blend Extreme Zinc SPF 50 | ZINC OXIDE, TITANIUM DIOXIDE | The Islander Group | 9b4acc5e-fdaf-4fcb-83a9-69e430dd43de | 2026-01-07 | 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 |