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 |
|---|---|---|---|---|---|---|
| Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN | HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE | Oracle Cosmetic Co., Ltd. | 21424f78-f8d5-6a9b-e063-6294a90ab7dc | 2026-02-02 | Warnings | M020 |
| HAMPTON SUN SPF50 SUNSHIELD BODY GLOW | HOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5% | S&C Hampton Sun LLC | 26190992-9463-47ae-86a5-0dbc05be8773 | 2026-02-02 | Warnings | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE | Rite Aid Corporation | fe9146ec-b85d-43da-a391-377960f2c772 | 2026-02-02 | Warnings, Adverse reactions | M020 |
| sheer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Rite Aid Corporation | 299a6690-9746-4410-a625-7636f0b4a754 | 2026-02-02 | Warnings, Adverse reactions | M020 |
| Dr. C. Tuna Sun Stick SPF 50 | AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE | Farmasi US LLC | 49dc6040-b400-7f5b-e063-6394a90ac7d7 | 2026-02-02 | Warnings | M020 |
| Naturium Dew Glow Moisturizer Mineral SPF 50 | ZINC OXIDE | e.l.f. Cosmetics, Inc | 535f798f-d21d-92b2-e063-6294a90a72c7 | 2026-02-02 | Warnings | M020 |
| Sol de Janiero Rio Radiance SPF 50 Body | ZINC OXIDE | Cosmetic Solutions LLC | 2d54727d-5dcc-4792-85e8-1a2f21fe9e3d | 2026-02-02 | Warnings | M020 |
| Sky and Sol Face and Body Sunscreen Spf 50 | ZINC OXIDE | Delta Ecommerce LLC | 47d9dc66-328f-4cab-e063-6394a90a279d | 2026-02-01 | Warnings | M020 |
| e.l.f. Suntouchable Invisi-Stick Glitz SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f cosmetics,Inc. | 4b801bb3-8930-7e04-e063-6294a90adaa1 | 2026-02-01 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR CLEAR | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | cedd7a3e-3334-437f-a283-482bcd0064ee | 2026-01-30 | Warnings | M020 |
| SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | bf16e8b5-b717-4255-a7da-9abe3d1ad8b4 | 2026-01-30 | Warnings | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Rite Aid Corporation | 372a8fba-b190-40fe-a1fc-fecf7f7afc35 | 2026-01-30 | Warnings, Adverse reactions | M020 |
| ALOE UP MEDICATED LIP BALM SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Aloe Care International, LLC | 859b6d3f-b1ca-4966-8f0c-f9afa0d5864c | 2026-01-30 | Warnings | M020 |
| ALOE UP SPORT NATURAL BALM SPF-15 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Aloe Care International, LLC | 3de029ed-97f7-4cb3-a32e-d412bf3b5874 | 2026-01-30 | Warnings | M020 |
| Reef safe unscented SPF 50 mineral sunscreen 01 | TITANIUM DIOXIDE, ZINC OXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 49a77ad4-508c-9617-e063-6394a90a5623 | 2026-01-30 | Warnings | M020 |
| JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33 | TITANIUM DIOXIDE AND ZINC OXIDE | Cosmetic Solutions LLC | d65ae1c9-dff5-4612-b8be-fa59bba03b81 | 2026-01-30 | Warnings | M020 |
| Touch in SOL No Poreblem Airbrushed Primer | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | BONNE Co., Ltd | 4685ff24-0bb0-3502-e063-6394a90abfee | 2026-01-29 | Warnings | M020 |
| Sheer Touch Sunscreen SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE | Aldi, Inc | c7650d20-7cb9-4861-8a30-cf4a9cd424e9 | 2026-01-29 | Warnings, Adverse reactions | M020 |
| Sunscreen SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE | Aldi, Inc | 32c0613e-0f5a-47f5-b2f3-f32ae07cbc76 | 2026-01-29 | Warnings, Adverse reactions | M020 |
| Vacation Original Coconut SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Vacation INC. | a9a0b558-b8e6-44ea-9b57-6938837a04fb | 2026-01-29 | 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 |