Home NDC 82975-101 Hydrating Body Sunscreen
Product NDC 82975-101
11-digit product format 829750101
Labeler code 82975
Product ID 82975-101_e8bb47dd-7d81-1647-e053-2995a90ac881
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octocrylene, Octisalate, Avobenzone
Dosage form LOTION
Route TOPICAL
Labeler frank body
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-12-31
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 82975-101-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 82975-101-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 82975-101-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 82975-101-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 82975-101-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82975-101 HYDRATING BODY SUNSCREEN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [FRANK BODY] 2 Legacy NDC 20250201_e8bb47dd-7d80-1647-e053-2995a90ac881.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 239 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE PURA VIDA BODY & MIND SPA, INC. 04b38e97-c4b3-df23-e063-6394a90ae6b7 2025-01-08 Warnings Exact identifier application number: M020 EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Premier Plastic Surgery bc9221fe-89b4-4ad8-e053-2995a90aa041 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Emerald Aesthetics LLC f80f439d-f4f0-fbf3-e053-6294a90ae0ef 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Suzanne's Skin2soul LLC fea667a1-6bec-9819-e053-6394a90a9b96 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE BEAUTY SENSE MEDSPA INC fe93a337-8d2f-35d3-e053-6294a90acb3c 2025-01-08 Warnings Exact identifier application number: M020 Sunscreen Emulsion SPF50plus OCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE Guangzhou Senmai Biotechnology Co. 1d560670-026b-bd34-e063-6394a90a9af4 2025-01-08 Warnings Exact identifier application number: M020 Allies of Skin Sunless Tan SPF 50 Daily Self Tanner AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE ALLIES GROUP PTE. LTD. 4d58de8e-875b-4b77-b0ef-b9d760aaced8 2025-01-07 Warnings Exact identifier application number: M020 Pop Zinc Sunscreen ZINC OXIDE Guangzhou Haishi Biological Technology Co., Ltd 2b29ddb2-5730-8a67-e063-6394a90ae416 2025-01-07 Warnings Exact identifier application number: M020 COOLA Anti-Aging Sun Silk Drops Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUM COOLA LLC bbb29d0c-ae1f-409e-8fd6-ff3ea34dc9c2 2025-01-07 Warnings Exact identifier application number: M020 Advanced Day Ultimate Protect Sunscreen SPF 50 BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE Medik8 Limited 29071920-ba90-871a-e063-6294a90aee27 2025-01-06 Warnings Exact identifier application number: M020 Dimples Bath Co - Sunstick New Kid On The Block ZINC OXIDE Dimples Bath Co. LLC 26f682f4-2440-f111-e063-6294a90ab4b7 2025-01-06 Warnings Exact identifier application number: M020 Diaper Rash Cream Happy Cheeks DIAPER RASH HAPPY CHEEKS Dimples Bath Co. LLC 26cef2eb-a133-11ec-e063-6394a90a0f08 2025-01-06 Warnings Exact identifier application number: M020 New Kid on the Block ZINC OXIDE Dimples Bath Co. LLC 26fec959-c234-6692-e063-6394a90a6600 2025-01-06 Warnings Exact identifier application number: M020 New Kid on the Block ZINC OXIDE Dimples Bath Co. LLC 26f85758-820f-3f73-e063-6294a90a289d 2025-01-06 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Spritz Face Mist HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE BONDI SANDS (USA) INC. 2b0f0b56-233f-4c6a-e063-6394a90aea6f 2025-01-06 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Spritz Body Mist HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE BONDI SANDS (USA) INC. 2b0fe721-b92a-4181-e063-6394a90a846a 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 56 Sunscreen Stick Sheer ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC 92c4e4cb-aadc-26f4-e053-2995a90a03d5 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 56 Sunscreen Compact Sheer ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC b8a4986d-c28f-c4f4-e053-2a95a90a7167 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone Smart ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC 8f119447-045b-43f3-e053-2995a90aea77 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC b878ee3b-6897-3c4a-e053-2995a90afed7 2025-01-06 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82975-101-01 82975010101 140 mL in 1 BOTTLE, PLASTIC (82975-101-01) 140 ml 2022-12-31 0000-00-00 No No Current