FDA.reportPublic FDA data

5281 SUNSCREEN

Product NDC
76138-219
Requested package NDC
76138-219-05
11-digit product format
761380219
Labeler code
76138
Product ID
76138-219_1cee97c2-00a1-c8b8-e063-6294a90ac4c6
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octocrylene, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Innovation Specialties
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-10
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
5281 SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTOCRYLENE50 mg/mL
OCTISALATE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86fc4539-e1c5-4d0f-a418-f48729cb2b20Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76138-219-052024-01-30C16284748780-11030e365-4bd2-111a-e063-dadaa90a10e25281 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-219-055281 SUNSCREEN15 mL in 1 BOTTLELOTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-2195281 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [INNOVATION SPECIALTIES]3Current NDC, Legacy NDC, 1 package rows20240712_86fc4539-e1c5-4d0f-a418-f48729cb2b20.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 1 of 359 · 7,165 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeoStrata Skin Active Matrix Support SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.8e4b9c08-b906-4c5f-a243-55838ae28b902026-07-29WarningsExact identifier
application number: M020
Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.4739e678-ce51-4863-bb74-2275879e1b472026-07-29WarningsExact identifier
application number: M020
MELAO GHK-Cu PEPTIDE SUNSCREENBUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENEGuangdong Aimu Biological Technology Co., Ltd57a8c34a-d6c9-c03e-e063-6394a90a7af12026-07-29WarningsExact identifier
application number: M020
BelleJoss BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c07f29-2e23-d18a-e063-6394a90a10202026-07-29WarningsExact identifier
application number: M020
BemeJolie BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c27cea-bb0c-5d2d-e063-6394a90a1b482026-07-29WarningsExact identifier
application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 UnscentedZINC OXIDEThe Procter & Gamble Manufacturing Company3a89238b-d1ee-d7fa-e063-6294a90ae55f2026-07-28WarningsExact identifier
application number: M020
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Companydfb1b42e-c821-1a41-e053-2995a90acf952026-07-28WarningsExact identifier
application number: M020
LUXE COLOR FOUNDATIONOCTINOXATE 7% ZINC OXIDE 5%Guangzhou Huixue Biotechnology Co., Ltd.576c3496-702f-808c-e063-6394a90a53c32026-07-25WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 KitAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEXact Packing Limited5759058d-e683-f3fc-e063-6394a90abc012026-07-24WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHTZINC OXIDEYounique, LLCf93d42a9-b655-4b75-a16d-b29f38f04efc2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUMZINC OXIDEYounique, LLC82769819-b229-4864-9b3c-44f49a68a53a2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIRZINC OXIDEYounique, LLCed700cae-8226-48d9-93ba-03154aa1cae52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHTZINC OXIDEYounique, LLCd728b89c-692f-485b-88c3-929b2f0350d52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUMZINC OXIDEYounique, LLCa49dfff1-e9ec-4573-90b0-ef6a7226aa562026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARKZINC OXIDEYounique, LLCcc576b63-caf4-491d-8d7f-027b1127133b2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARKZINC OXIDEYounique, LLC2173666b-6c72-449d-9f40-098ea174f3e12026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK DEEPZINC OXIDEYounique, LLC360ceb90-bec6-4fec-820a-a4d65008b8722026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DEEPZINC OXIDEYounique, LLC86c33a9e-9132-4377-8688-41e5844de62c2026-07-23WarningsExact identifier
application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN MOISTUREAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEForest Avenue Co., Ltd.edbfcf21-96c6-4519-8b08-f9b5ada7d1d72026-07-23WarningsExact identifier
application number: M020
SKINSUIT LIP SPF 30ZINC OXIDESkin Authority LLCcb24d714-f6cd-4518-b146-627cfe6c2ccd2026-07-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76138-219-057613802190515 mL in 1 BOTTLE (76138-219-05) 15 ml2022-05-100000-00-00NoNoCurrent