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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82975-101DDiscontinued by firm2026-11-13
excluded packagepackage82975-10182975-101-01DDiscontinued by firm2026-11-13

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage82975-101-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage82975-101-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage82975-101-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage82975-101-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82975-101-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82975-101-012025-02-01C16284748780-12cef2736-ace4-d83d-e063-dadaa90ab31fHydrating Body Sunscreen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82975-101HYDRATING BODY SUNSCREEN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [FRANK BODY]2Legacy NDC20250201_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 312 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETekweld Solutions, Inc.ea9f4d57-b00c-48ce-b833-9690be98bffd2023-12-26WarningsExact identifier
application number: M020
Best Skin Days BS SPF 30ZINC OXIDEAllure Labs0d7072f8-e808-5270-e063-6294a90a1ffa2023-12-26WarningsExact identifier
application number: M020
Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incf0d6518b-d795-4740-a301-1804a932ec452023-12-23WarningsExact identifier
application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy GlowOCTINOXATEL'Oreal USA Products Inc4f4a8c37-af08-4bf7-89bc-1e487417c1462023-12-23WarningsExact identifier
application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy GlowOCTINOXATESICOS ET CIE7051f505-f874-4214-ad4f-55a956cc35a72023-12-23WarningsExact identifier
application number: M020
Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating DayAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc08645f1d-7ba7-4410-8600-3d3f79d713852023-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift and Firming Face and Neck All Skin TypesAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incfc847725-b7a9-41f1-a605-d1d892fed06f2023-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift Firming Face Neck For All Skin TypesAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEdf67b49c-f8b6-4c0a-9e8d-c94dee3635ff2023-12-23WarningsExact identifier
application number: M020
Lancome Paris Absolue Premium Bx Replenishing Rejuvenating Broad Spectrum SPF 15 DayAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEa9b7e52c-8799-49ba-8b05-7559fe6668fe2023-12-23WarningsExact identifier
application number: M020
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen fairTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.32569352-c51e-4f05-a8b0-749ef916a5af2023-12-22WarningsExact identifier
application number: M020
Circadia Circa-Shield Mineral Sunscreen SPF 30ZINC OXIDECircadia by Dr Pugliese, Inc.2959aa56-be7f-4721-9701-e6d6e12cc8502023-12-22WarningsExact identifier
application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc0adb52f5-4e1f-4570-9b6f-584e4da61d9f2023-12-22WarningsExact identifier
application number: M020
ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCc670635a-63d8-4b0b-afd7-b26e969f93a12023-12-21WarningsExact identifier
application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 16N fair-light neutralTITANIUM DIOXIDETarte, Inc.62fffef6-29ae-4137-b0b9-fb93d61679332023-12-21WarningsExact identifier
application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 12N fair neutralTITANIUM DIOXIDETarte, Inc.889860fc-7fce-47e9-af28-a3b2aec04a0e2023-12-21WarningsExact identifier
application number: M020
JLo Beauty That Big Screen Broad Spectrum SPF 30 MoisturizerHOMOSALATE, OCTISALATE, AND ZINC OXIDEAscendant Beauty LLCcba4e886-c4c6-4377-8f4c-250aef4b95fb2023-12-21WarningsExact identifier
application number: M020
COOLA Full Spectrum 360 Refreshing Water Cream SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLCd12e30bd-88ee-4e34-ae63-c34766aed3a82023-12-20WarningsExact identifier
application number: M020
COOLA Liplux Hydrating Oil SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC2d2ad94c-ea13-43c0-ab7f-acecf4d2309f2023-12-20WarningsExact identifier
application number: M020
Coola Bare Republic Mineral Face-Lotion SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%COOLA LLCa334a61d-5c5a-4f45-b202-6dd7bb3d250b2023-12-20WarningsExact identifier
application number: M020
Bare Republic Big Adventure Stick SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9%COOLAe800f72f-8c8b-4a12-843f-1ee404055cf02023-12-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82975-101-0182975010101140 mL in 1 BOTTLE, PLASTIC (82975-101-01) 140 ml2022-12-310000-00-00NoNoCurrent