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 |
|---|---|---|---|---|---|---|
| SPF Lip Colour | ZINC OXIDE | Lauren Brooke Cosmetiques, LLC | 50b344b5-e39d-48ef-e063-6394a90ae41c | 2026-04-30 | Warnings | M020 |
| No 7 Prime Forever SPF 50 Primer | NO 7 PRIME FOREVER BROAD SPECTRUM SUNSCREEN SPF50 PRIMER | Boots Retail USA | 50b3e9fa-faf8-0026-e063-6294a90a0823 | 2026-04-30 | Warnings | M020 |
| Tru Skin Rituals SPF 25 | TITANIUM DIOXIDE, ZINC OXIDE | Spa de Soleil | f725cd5c-999e-2393-e053-6394a90a09dc | 2026-04-30 | Warnings | M020 |
| Moisture Sunscreen SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Spa de Soleil | cb95975f-060d-23c2-e053-2a95a90adf1b | 2026-04-30 | Warnings | M020 |
| Day Cream SPF 30 | OCTOCRYLENE, OCTINOXATE, AVOBENZONE | Anthony Skin LLC | 5070e8cc-12c0-c2c4-e063-6294a90a1422 | 2026-04-29 | Warnings | M020 |
| Steak n Shake Beef Tallow Sunscreen SPF 30 | ZINC OXIDE | HRR Enterprises, Inc | 0eb122d8-6826-4843-bed1-9e0cb8316e6d | 2026-04-29 | Warnings | M020 |
| EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Walmart | 509b6c7d-8a28-2d3a-e063-6394a90af068 | 2026-04-29 | Warnings | M020 |
| Freaks of Nature Solar Shield Broad Spectrum SPF 30 | FREAKS OF NATURE SOLAR SHIELD BROAD SPECTRUM SPF 30 | THE FREAKS OF NATURE, INC. | 509b8610-6dbe-611f-e063-6394a90a9fd1 | 2026-04-29 | Warnings | M020 |
| TiZO2 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 509cad98-0321-2a0a-e063-6294a90a6ea9 | 2026-04-29 | Warnings | M020 |
| TiZO2 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 509d7206-0cc1-c997-e063-6294a90a89e0 | 2026-04-29 | Warnings | M020 |
| COTZ FACE MOISTURE | ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 509d9a74-bc8d-c9c1-e063-6394a90a403d | 2026-04-29 | Warnings | M020 |
| JMSOLUTION MARINE LUMINOUS PEARL SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | GPNY CORP | 212d4563-2fad-31a5-e063-6394a90aff71 | 2026-04-29 | Warnings | M020 |
| JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREEN | HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE | GPNY CORP | 211dea04-faad-8ffc-e063-6294a90a8d68 | 2026-04-29 | Warnings | M020 |
| La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Bronze Cell OX Shield Broad Spectrum SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE | L'Oreal USA Products Inc | 5e19577b-9911-4fa1-a2b7-7ca2e02d1fd8 | 2026-04-28 | Warnings | M020 |
| Daily Defence Moisturising Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Ultraceuticals Pty Ltd | 50888d3f-46ae-e2c2-e063-6394a90ad6af | 2026-04-28 | Warnings | M020 |
| Anything SPF | OCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE | Anything SPF LLC | 508b8dcb-6600-6dad-e063-6294a90a565a | 2026-04-28 | Warnings | M020 |
| Fusion Water Magic | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE | ISDIN Corp. | d4f91d5a-600a-4255-a6e1-e7e7197848c7 | 2026-04-28 | Warnings | M020 |
| La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Pearl Cell OX Shield Broad Spectrum SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE | L'Oreal USA Products Inc | c6a1b995-1898-4a92-b128-7d5ebd6d8d3d | 2026-04-28 | Warnings | M020 |
| Obagi Skintrinsiq Antioxidant Protocol | AVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE, AND OXYBENZONE | Obagi Cosmeceuticals LLC | 53023b16-8d64-4dfc-bc75-b4f248425c4d | 2026-04-27 | Warnings | M020 |
| TONEfitSUN Sebum Control Vegan Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory | 506b96ae-eb2a-edad-e063-6294a90a470e | 2026-04-27 | 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 |