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 |
|---|---|---|---|---|---|---|
| DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY | AVOBENZONE, OCTINOXATE, OCTISALATE | KOS America, Inc. | 81352963-36ec-4099-af51-3498d89f3077 | 2025-12-23 | Warnings | M020 |
| Poolside Soft Serve Mineral Milk SPF 30 face sunscreen drops | ZINC OXIDE, OCTINOXATE | Longway Technology(Guangzhou)Co.,Ltd. | 451b4d37-99e2-8e4f-e063-6294a90a51bb | 2025-12-23 | Warnings | M020 |
| Reclaim Revolutionary Anti-Aging Day SPF15 | OCTINOXATE, OCTISALATE, AND OXYBENZONE | Guthy-Renker LLC | 4b735c91-f650-4531-8744-c211d57a3e28 | 2025-12-23 | Warnings | M020 |
| SCINIC ENJOY SUPER MILD SUN ESSENCE EX | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | ELEVEN STREET | 35272744-8253-046c-e063-6394a90aabc2 | 2025-12-22 | Warnings | M020 |
| TINTED FACIAL SUNSCREEN | ZINC OXIDE, TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 1259035e-9196-97de-e063-6394a90a9dec | 2025-12-22 | Warnings | M020 |
| SUNSCREEN LIP BALM | ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, POLYSILICONE-15, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE | Guangzhou Tata Biotechnology Co., Ltd. | 0f8e08bf-4b14-bdad-e063-6394a90a34e1 | 2025-12-22 | Warnings | M020 |
| SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15 | ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE | Guangzhou Tata Biotechnology Co., Ltd. | 1c32b019-a038-eb61-e063-6394a90a45f2 | 2025-12-22 | Warnings | M020 |
| SPF 50 MINERAL SUNSCREEN LIP | ZINC OXIDE , TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 1c6f0964-9bee-1c06-e063-6294a90ac2a4 | 2025-12-22 | Warnings | M020 |
| Absolut Skin SPF 50 Moisturizing Sunscreen | ETHYLHEXYL METHOXYCINNAMATE,ETHYLHEXYL SALICYLATE,METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL,OCTOCRYLENE | Guangzhou Tata Biotechnology Co., Ltd. | 3264543c-e8f5-da9a-e063-6394a90ac8c6 | 2025-12-22 | Warnings | M020 |
| Firmarine Moisturizer SPF 30 | AVOBENZONE, OCTINOXATE, AND OCTISALATE | Erno Laszlo, Inc. | 073f8b95-6f46-4341-817f-22f5b4f32542 | 2025-12-22 | Warnings | M020 |
| G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREEN | ZINC OXIDE, TITANIUM DIOXIDE | LABORATOIRES DERMO-COSMETIK INC. | 468c90d7-3b9e-1641-e063-6394a90a928c | 2025-12-22 | Warnings | M020 |
| TiZO3 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 468d6476-127a-e9f0-e063-6294a90a3df9 | 2025-12-22 | Warnings | M020 |
| YOUR SKIN BUT BETTER FAIR | TITANIUM DIOXIDE AND ZINC OXIDE | IT COSMETICS, LLC | 3e65ec1a-0ed9-433d-8da9-a6cb61829911 | 2025-12-22 | Warnings | M020 |
| Sun Shades Sunscreen Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Melaleuca Inc. | 1f982f03-9542-29f9-e063-6294a90a959c | 2025-12-22 | Warnings | M020 |
| SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTED | ZINC OXIDE | SOLARA SUNCARE, INC. | ca99b8c4-6778-43dc-bdd5-ca4a470860a0 | 2025-12-22 | Warnings | M020 |
| SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTED | ZINC OXIDE | SOLARA SUNCARE, INC. | f810843b-5a4d-6cbc-e053-6294a90ac9e3 | 2025-12-22 | Warnings | M020 |
| SOLARA SUNCARE - CLEAN FREAK SPF-30 NATURALLY SCENTED | ZINC OXIDE | SOLARA SUNCARE, INC. | 7a5644b9-4368-4e9a-aa22-b3307acf43cc | 2025-12-22 | Warnings | M020 |
| MINERAL DEFENSE SPORT CERAMIDE SPF-30 | ZINC OXIDE | SOLARA SUNCARE, INC. | cbf9c715-2d45-4c1b-b58f-42795722821c | 2025-12-22 | Warnings | M020 |
| SPF 50 Baby Sunscreen Equate | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Walmart Inc | 4690d89b-ae61-2ed5-e063-6294a90a743f | 2025-12-22 | Warnings | M020 |
| MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50 | ZINC OXIDE | SOLARA SUNCARE, INC. | f5242c7d-09e1-4141-8de1-a89bd7981ca6 | 2025-12-22 | 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 |