Home NDC 80641-016 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 table 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# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table 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# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80641-016 ORANGE GEL (AVOBENZONE OCTISALATE OCTOCRYLENE HOMOSALATE) GEL [VACATION INC.] 3 Current NDC, 2 package rows 20250420_132896ef-d6c6-4ec7-e063-6294a90a103b.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.
Matched openFDA labels page 237 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Earths Daughter Vanilla Bean SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad0db95-a283-3c91-e063-6294a90ae523 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Strawberry Breeze SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad129b7-4ecd-a967-e063-6294a90ad8c4 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Citrus Blast SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad18f4b-4251-be82-e063-6394a90acac5 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Creamy Coconut SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad1bb50-869e-8122-e063-6294a90ac724 2025-01-03 Warnings Exact identifier application number: M020 Glow Baby Brightening Setting Mist SPF 45 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Pacifica Beauty, LLC f2f53cf9-3717-07ff-e053-2a95a90a03fb 2025-01-03 Warnings Exact identifier application number: M020 Future Youth Daily Turnaround Hydrating Moisturizer SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Pacifica Beauty, LLC 0324275f-13bc-e7b8-e063-6294a90a6902 2025-01-03 Warnings Exact identifier application number: M020 Glow Baby Super Lit SPF 30 ZINC OXIDE Pacifica Beauty, LLC f3d3eee2-a5d9-113b-e053-2995a90a7057 2025-01-03 Warnings Exact identifier application number: M020 Kind Tint SPF 30 ZINC OXIDE Pacifica Beauty, LLC f421cbf7-cfae-5eae-e053-2995a90ab35c 2025-01-03 Warnings Exact identifier application number: M020 Vegan Collagen Every Day SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE Pacifica Beauty, LLC f449da32-5ade-2c78-e053-2a95a90a27a1 2025-01-03 Warnings Exact identifier application number: M020 Members Mark SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sam's West Inc 2b354ab6-f241-676f-e063-6394a90a5893 2025-01-03 Warnings Exact identifier application number: M020 Vanilla Mint Lip Balm LIP BALM Casad Company Inc. 3214bff3-e133-43ca-946d-f4c5dd074760 2025-01-03 Warnings Exact identifier application number: M020 Vanilla Lip Balm LIP BALM Casad Company Inc. d27398d3-98b0-4f70-997e-6ed02559594f 2025-01-03 Warnings Exact identifier application number: M020 Cherry Lip Balm LIP BALM Casad Company Inc. b262645e-f069-420d-90ac-9eb4b82236d8 2025-01-03 Warnings Exact identifier application number: M020 Peppermint Lip Balm LIP BALM Casad Company Inc. 46a4b6d1-37e4-471d-a41b-57afe8bd9f2f 2025-01-03 Warnings Exact identifier application number: M020 Beeswax Lip Balm LIP BALM Casad Company Inc. 5301398d-82f8-495e-b3ec-0938eca16369 2025-01-03 Warnings Exact identifier application number: M020 Spearmint Lip Balm LIP BALM Casad Company Inc. ba9b5420-60b0-4528-9898-a0a5287a2aee 2025-01-03 Warnings Exact identifier application number: M020 Pomegranate Lip Balm LIP BALM Casad Company Inc. 4e943a8a-f627-4e28-bdd7-c2b63be5dca3 2025-01-03 Warnings Exact identifier application number: M020 Tropical Lip Balm LIP BALM Casad Company Inc. 5e730d21-b810-4b84-9c85-0343ab0c8d5a 2025-01-03 Warnings Exact identifier application number: M020 Green Defense Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Farmacy Beauty LLC adf0f50f-6357-bc1f-e053-2a95a90ad997 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Bamboo ZINC OXIDE EVER FAME PTE. LTD. 2abbc7fb-ea5d-9c68-e063-6394a90a88d2 2025-01-02 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table 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