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 |
|---|---|---|---|---|---|---|
| Ray Defense Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Bioelements | 807db1ff-a64a-44e4-a786-f88cd4518433 | 2025-12-17 | Warnings | M020 |
| SPF 50 Face Sunscreen Bioelements | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Bioelements, Inc | 981c7b3c-d7d6-483d-bf32-10d526be5b3f | 2025-12-17 | Warnings | M020 |
| Glow Oil SPF 50 Beach Flower | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Supergoop, LLC | 2a46d7d2-293f-5024-e063-6294a90a31aa | 2025-12-17 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 15 | AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% | Beiersdorf Inc | 0f114022-daaa-1834-e063-6394a90afd1d | 2025-12-17 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 8 | AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% | Beiersdorf Inc | 0f113048-adfb-7d2a-e063-6294a90a2012 | 2025-12-17 | Warnings | M020 |
| Coppertone Oil Free and Shine Control Face Sunscreen SPF 45 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | f3d163b4-6774-4c2e-e053-2a95a90afd59 | 2025-12-17 | Warnings | M020 |
| Coppertone EveryTone Face Sunscreen SPF 55 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 04b12f39-778c-ecee-e063-6394a90afa24 | 2025-12-17 | Warnings | M020 |
| Skin On Skin BC Foundation SPF 40 - Fair Cool | OCTISALATE, HOMOSALATE, ZINC OXIDE | YENSA Beauty, LLC | 462e9a4a-ef28-0e0e-e063-6394a90ab4f8 | 2025-12-17 | Warnings | M020 |
| Mattifying Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | b27d7df0-3c84-4cc5-9ef3-07105311fed9 | 2025-12-17 | Warnings | M020 |
| Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40 | TITANIUM DIOXIDE, ZINC OXIDE | Galderma Laboratories, L.P. | 45d101be-2b88-4759-9ccc-556f5ec0553d | 2025-12-17 | Warnings | M020 |
| Brightening Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | a42d6761-47cd-4c9b-9656-64e37e065639 | 2025-12-17 | Warnings | M020 |
| Avail Body with Sunscreen | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Emeis Cosmetics Pty Ltd | 4bb39ea1-f948-4357-b425-0cafd454ce30 | 2025-12-17 | Warnings | M020 |
| Bronzing Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | f749af07-0fcd-4376-be62-7c078b3e7eb6 | 2025-12-17 | Warnings | M020 |
| Miffy Tone Perfecting SPF Cushion | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | RBGROUP Co., Ltd | 98a2906d-61e2-4627-a695-a20f10872f9a | 2025-12-16 | Warnings | M020 |
| Dear Sun Tone Perfecting SPF Cushion | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | RBGROUP Co., Ltd | 80748647-e0ea-46dc-8ee2-a0ad77c4b19d | 2025-12-16 | Warnings | M020 |
| SUNSCREEN Stick | ZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6% | Foshan Sugar Max Cosmetics CO.,Ltd | 460e1038-30f0-a6e4-e063-6394a90ad534 | 2025-12-16 | Warnings | M020 |
| SUNSCREEN SPRAY150ml | ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4% | Foshan Sugar Max Cosmetics CO.,Ltd | 460ead6c-dd44-e320-e063-6294a90a2b64 | 2025-12-16 | Warnings | M020 |
| Sunscreen Cream | ZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5% | Foshan Sugar Max Cosmetics CO.,Ltd | 460f0ca0-9440-9a6e-e063-6394a90a33b3 | 2025-12-16 | Warnings | M020 |
| Unseen Sunscreen Lip Protector SPF 30 | OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE | Supergoop LLC | db12a89f-5fef-1b2a-e053-2a95a90a56f9 | 2025-12-16 | Warnings | M020 |
| Tinted Mineral Sunscreen | ZINC OXIDE | Natur LLC | 365f3c48-15a6-2d32-e063-6394a90aad78 | 2025-12-16 | 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 |