Orange Gel
- Product NDC
- 80641-016
- 11-digit product format
- 806410016
- Labeler code
- 80641
- Product ID
- 80641-016_b99c06a3-7b97-4257-bd0c-8a9f3f6297de
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone Octisalate Octocrylene Homosalate
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Vacation Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-03-08
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 2.9; 6.9; 4.9; 9.5 g/100g; g/100g; g/100g; g/100g
- 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
- Orange Gel
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AVOBENZONE | 2.9 g/100g |
| HOMOSALATE | 6.9 g/100g |
| OCTISALATE | 4.9 g/100g |
| OCTOCRYLENE | 9.5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G63QQF2NOX | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 132896ef-d6c6-4ec7-e063-6294a90a103b | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80641-016-02 | Orange Gel | 2 in 1 CARTON | GEL | 2 | 4 | |
| 80641-016-30 | Orange Gel | 88 g in 1 TUBE | GEL | 88 | 4 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Perfecting Blendrops Broad Spectrum SPF 40 | HOMOSALATE, OCTISALATE, ZINC OXIDE | Wasatch Product Development, LLC | 12512cac-652e-b138-e063-6394a90ad1f2 | 2025-12-09 | Warnings | M020 |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | ASHLEY SAMAI | 38f457fa-0e95-7298-e063-6394a90adda8 | 2025-12-09 | M020 | |
| Non-Tinted Mineral Sunscreen | ZINC OXIDE | OLGA KLIMOV INC | 387b41a4-057f-88af-e063-6394a90adbbe | 2025-12-09 | M020 | |
| Tinted Replenishing Daily Protection | ZINC OXIDE | OLGA KLIMOV INC | 387b8ae6-c48b-905c-e063-6394a90a31fb | 2025-12-09 | M020 | |
| Tinted Primer Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | CECILIA EDWARDS | 36ea709b-3536-5052-e063-6394a90a48f9 | 2025-12-09 | M020 | |
| Age Defying Mineral Protection | TITANIUM DIOXIDE, ZINC OXIDE | MARK SCHWARTZ CLINICAL SKINCARE, INC. | 3b028159-f240-2cf2-e063-6294a90a32b5 | 2025-12-09 | Warnings | M020 |
| Ultimate Mineral Protection | ZINC OXIDE | MARK SCHWARTZ CLINICAL SKINCARE, INC. | 3b02bf69-b648-56e1-e063-6294a90aeef3 | 2025-12-09 | Warnings | M020 |
| G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN | ZINC OXIDE, TITANIUM DIOXIDE | LABORATOIRES DERMO-COSMETIK INC. | 01dcfd14-7a1d-98fa-e063-6294a90a0336 | 2025-12-09 | Warnings | M020 |
| Tinted Primer Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | CECILIA EDWARDS | 3aff2074-1514-b5c5-e063-6394a90a7572 | 2025-12-09 | M020 | |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER | 3729d270-64ac-4d2e-e063-6294a90aeb2c | 2025-12-09 | M020 | |
| Non Tinted Replenishing Daily Protection | ZINC OXIDE | LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER | 372a41f6-40f6-4971-e063-6394a90a83e0 | 2025-12-09 | M020 | |
| Stay Shady Non-Tinted Mineral Sunscreen | ZINC OXIDE | AMOIE ALAYVILLA | 3b277237-3a2e-1fb0-e063-6294a90adf20 | 2025-12-09 | Warnings | M020 |
| Stay Shady Non-Tinted Mineral Sunscreen | ZINC OXIDE | AMOIE ALAYVILLA | 3b27225f-4589-d915-e063-6294a90a7225 | 2025-12-09 | Warnings | M020 |
| Replenishing Tinted Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Beauty Journey Studio LLC | 3738a0c3-5c07-e49b-e063-6394a90a38e9 | 2025-12-09 | M020 | |
| Replenishing Non Tinted Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Beauty Journey Studio LLC | 37385fc6-1cde-8aa6-e063-6294a90a6017 | 2025-12-09 | M020 | |
| Replenishing Tinted Sunscreen | ZINC OXIDE | Beauty Journey Studio LLC | 3738e5e0-f6d9-0568-e063-6294a90a67b6 | 2025-12-09 | M020 | |
| JAYSUING Matte Sun Stick | TITANIUM DIOXIDE | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 456b44da-02f3-93a0-e063-6294a90a8d06 | 2025-12-08 | Warnings | M020 |
| JAYSUING Matte Sun Stick | TITANIUM DIOXIDE | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 456c2974-d499-7841-e063-6294a90a98eb | 2025-12-08 | Warnings | M020 |
| JAYSUING Ginseng Moist Sun Serum | TITANIUM DIOXIDE | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 456cfa70-f524-f5cb-e063-6394a90ae7dc | 2025-12-08 | Warnings | M020 |
| Face and Body Sunscreen | NON-NANO ZINC OXIDE 25% | Guangzhou Shengyanghui Industrial Trading Co., Ltd | 3ee96538-06e8-75b1-e063-6394a90a5285 | 2025-12-08 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80641-016-02 | 80641001602 | 2 TUBE in 1 CARTON (80641-016-02) / 88 g in 1 TUBE (80641-016-30) | 2 tube | 2025-04-18 | No | No | Current |
| 80641-016-30 | 80641001630 | 88 g in 1 TUBE (80641-016-30) | 88 g | 2024-03-08 | No | No | Current |