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 |
|---|---|---|---|---|---|---|
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 228fab45-e0d2-f219-e063-6294a90a1ef6 | 2026-01-05 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 228055ec-ff59-4412-e063-6394a90abe14 | 2026-01-05 | Warnings | M020 |
| SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 236bdb53-d7a5-43a2-8a0c-bce4a5522e26 | 2026-01-05 | Warnings | M020 |
| SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 4bd99626-690b-49e8-8c42-a2e2dbca09bf | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE LONG-LASTING HYDRATING VEIL | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | f04ece6c-66b6-48e9-8f6b-e898a538ba00 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE RADIANT FOUNDATION N I10 | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 05ffb157-5e28-4e94-866d-9e3371480d84 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE CONCEALER N 1 | TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | eedf8065-8897-4773-9cbb-bab57d2dd04f | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE BRIGHTENING ENHANCER VEIL | OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | bb00d6d7-cc51-4fee-a0df-68bbd5bc50d6 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | beefe840-6f32-483b-8a37-2696adb8eea1 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25 | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | addd9885-362c-4ce0-9a6e-759e71d8756c | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE PROTECTIVE FORTIFYING n | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 65ca1240-6ee8-40c0-b62f-3597e0872c6e | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE CORRECTING VEIL n M | ENSULIZOLE, OCTINOXATE, AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 15a258a0-61c3-4419-bcdb-a8197d5ae46f | 2026-01-05 | Warnings | M020 |
| Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | LG H&H Co.,Ltd. | 098c0a9b-2b96-6be3-e063-6294a90a959a | 2026-01-05 | Warnings | M020 |
| Poolside Butter Screen SPF 30 Sunscreen Butter | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | ae838725-79ab-4c17-905b-d4138ad6af1f | 2026-01-05 | Warnings | M020 |
| Poolside Bronze Service Instant Bronzing Sunscreen SPF 30 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE | I World LLC | b98a9cec-3c48-4614-b091-4e59fa7d196e | 2026-01-05 | Warnings | M020 |
| Poolside Orange Creme SPF 30 Sunscreen Oil Mist | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | 5a9f8888-529d-40d7-9489-baa5ff657cb4 | 2026-01-05 | Warnings | M020 |
| Yon-Ka 50 Mineral Fluid | ZINC OXIDE | Laboratoire MULTALER Yon-Ka | 47a8c8b2-30ff-0d40-e063-6294a90ac461 | 2026-01-05 | Warnings | M020 |
| SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E | OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 6d2f82d5-b3af-44af-b6b0-de96a4cd95fc | 2026-01-05 | Warnings | M020 |
| SHISEIDO SPORTS BB LIGHT | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 260a3eab-8fe6-4259-8dcc-3706ca1f6881 | 2026-01-05 | Warnings | M020 |
| SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATE | SHISEIDO AMERICAS CORPORATION | 4a16dbb7-e860-4aae-8e8b-67abbe8295bd | 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 |