FDA.reportPublic FDA data

SUNSCREEN

Product NDC
82953-023
11-digit product format
829530023
Labeler code
82953
Product ID
82953-023_202ea60a-5a91-2b37-e063-6394a90a66df
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone,Homosalate,Octocrylene,Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-30
Substance
OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE
Active strength
10; 10; 3; 5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
SUNSCREEN
Brand name suffix
01
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE10 g/100mL
HOMOSALATE10 g/100mL
AVOBENZONE3 g/100mL
OCTISALATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal 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
202e99ef-330e-ad94-e063-6294a90a2d2aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-023-01SUNSCREEN0115 mL in 1 BOTTLE, PLASTICLOTION151
82953-023-02SUNSCREEN0130 mL in 1 BOTTLE, PLASTICLOTION301
82953-023-03SUNSCREEN0160 mL in 1 BOTTLE, PLASTICLOTION601
82953-023-04SUNSCREEN0175 mL in 1 BOTTLE, PLASTICLOTION751
82953-023-05SUNSCREEN0135 mL in 1 BOTTLE, PLASTICLOTION351
82953-023-06SUNSCREEN0150 mL in 1 BOTTLE, PLASTICLOTION501
82953-023-07SUNSCREEN01120 mL in 1 BOTTLE, PLASTICLOTION1201
82953-023-08SUNSCREEN01240 mL in 1 BOTTLE, PLASTICLOTION2401
82953-023-09SUNSCREEN01300 mL in 1 BOTTLE, PLASTICLOTION3001
82953-023-10SUNSCREEN0190 mL in 1 BOTTLE, PLASTICLOTION901
82953-023-11SUNSCREEN0120 mL in 1 BOTTLE, PLASTICLOTION201
82953-023-12SUNSCREEN0145 mL in 1 BOTTLE, PLASTICLOTION451
82953-023-13SUNSCREEN011.5 mL in 1 POUCHLOTION1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-023SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) LOTION [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 13 package rows20240822_202e99ef-330e-ad94-e063-6294a90a2d2a.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 38 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC507560fe-c7ad-329a-e063-6394a90a039a2026-04-27WarningsExact identifier
application number: M020
SoloVeganHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEYES SALES INC.435748e6-c39a-efee-e063-6294a90ad0e52026-04-27WarningsExact identifier
application number: M020
SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC50764f40-7881-81a3-e063-6294a90ad1cf2026-04-27WarningsExact identifier
application number: M020
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC495bc176-b292-448f-a5a6-00de2e475e542026-04-27WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf45bd7bd-a802-33e4-e053-2a95a90a61a72026-04-23WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERPML NYC, LLC1c2e9b0d-ba0e-1767-e063-6394a90a756c2026-04-23WarningsExact identifier
application number: M020
Skincare LdeL Retinol Day Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATEBeauty Solutions, Ltd.76e2ed34-c643-402b-9c9d-04eac789d3c22026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen Stick SPF 50ZINC OXIDEKenvue Brands LLC4fe1d3c6-7748-d966-e063-6394a90a97ff2026-04-22WarningsExact identifier
application number: M020
OVERLAPS ECTOIN MOIST SUNAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOverlaps Corp.4c3ed60b-e515-8ff0-e063-6294a90a86df2026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacestickZINC OXIDESunny Day Creations50101b55-793e-dbe4-e063-6394a90a61992026-04-22WarningsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3%S&C Hampton Sun LLCe6103de6-1d80-46fd-b9d4-893f60941def2026-04-22WarningsExact identifier
application number: M020
PhotoAge GuardAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMACROMOTION, INC.50164bd8-469d-9ec1-e063-6294a90a543d2026-04-22WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Silky Calming Sun StickAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD49947114-5137-dc45-e063-6394a90ad9d02026-04-22WarningsExact identifier
application number: M020
Sky and Sol Intense Healing Lip JellyNON-NANO ZINC OXIDEDelta Ecommerce LLC2ddaa215-7433-c8fa-e063-6394a90a43162026-04-22WarningsExact identifier
application number: M020
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLC0445ee5f-45a8-4fd5-ae4d-62f66e6f0be82026-04-21WarningsExact identifier
application number: M020
BLDG Active Skin Repair Face and Body Performance SunscreenZINC OXIDEInnovacyn, Inc.70cb98cf-739b-4d46-b45a-535ff0a4531c2026-04-21WarningsExact identifier
application number: M020
Freaks of Nature Mineral SunscreenZINC OXIDE MINERAL SUNSCREENEmpack Spraytech Inc.4ffdb1c6-b2c6-628f-e063-6394a90a27692026-04-21WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Water Sun CreamAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD5004126b-0a9c-21fb-e063-6294a90a52372026-04-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-023-018295300230115 mL in 1 BOTTLE, PLASTIC (82953-023-01) 15 ml2024-05-30NoNoCurrent
82953-023-028295300230230 mL in 1 BOTTLE, PLASTIC (82953-023-02) 30 ml2024-05-30NoNoCurrent
82953-023-038295300230360 mL in 1 BOTTLE, PLASTIC (82953-023-03) 60 ml2024-05-30NoNoCurrent
82953-023-048295300230475 mL in 1 BOTTLE, PLASTIC (82953-023-04) 75 ml2024-05-30NoNoCurrent
82953-023-058295300230535 mL in 1 BOTTLE, PLASTIC (82953-023-05) 35 ml2024-05-30NoNoCurrent
82953-023-068295300230650 mL in 1 BOTTLE, PLASTIC (82953-023-06) 50 ml2024-05-30NoNoCurrent
82953-023-0782953002307120 mL in 1 BOTTLE, PLASTIC (82953-023-07) 120 ml2024-05-30NoNoCurrent
82953-023-0882953002308240 mL in 1 BOTTLE, PLASTIC (82953-023-08) 240 ml2024-05-30NoNoCurrent
82953-023-0982953002309300 mL in 1 BOTTLE, PLASTIC (82953-023-09) 300 ml2024-05-30NoNoCurrent
82953-023-108295300231090 mL in 1 BOTTLE, PLASTIC (82953-023-10) 90 ml2024-05-30NoNoCurrent
82953-023-118295300231120 mL in 1 BOTTLE, PLASTIC (82953-023-11) 20 ml2024-05-30NoNoCurrent
82953-023-128295300231245 mL in 1 BOTTLE, PLASTIC (82953-023-12) 45 ml2024-05-30NoNoCurrent
82953-023-13829530023131.5 mL in 1 POUCH (82953-023-13) 1.5 ml2024-05-30NoNoCurrent