FDA.reportPublic FDA data

SUNSCREEN

Product NDC
82953-025
11-digit product format
829530025
Labeler code
82953
Product ID
82953-025_229d8002-259a-f252-e063-6394a90adda1
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone,Homosalate,Octocrylene,Octisalate
Dosage form
SPRAY
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
229dabbc-9043-3c9d-e063-6394a90a5692Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-025-01SUNSCREEN0110 mL in 1 BOTTLE, PLASTICSPRAY101
82953-025-02SUNSCREEN0120 mL in 1 BOTTLE, PLASTICSPRAY201
82953-025-03SUNSCREEN0125 mL in 1 BOTTLE, PLASTICSPRAY251
82953-025-04SUNSCREEN0115 mL in 1 BOTTLE, PLASTICSPRAY151
82953-025-05SUNSCREEN018 mL in 1 BOTTLE, PLASTICSPRAY81
82953-025-06SUNSCREEN0118 mL in 1 BOTTLE, PLASTICSPRAY181
82953-025-07SUNSCREEN015 mL in 1 BOTTLE, PLASTICSPRAY51
82953-025-08SUNSCREEN0130 mL in 1 BOTTLE, PLASTICSPRAY301
82953-025-09SUNSCREEN0160 mL in 1 BOTTLE, PLASTICSPRAY601
82953-025-10SUNSCREEN0190 mL in 1 BOTTLE, PLASTICSPRAY901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-025SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) SPRAY [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 10 package rows20240922_229dabbc-9043-3c9d-e063-6394a90a5692.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 292 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bitchstix Very Raspberry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77e9c3-cffe-0bb6-e063-6294a90aacd12024-07-17WarningsExact identifier
application number: M020
Bitchstix The Original SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchistix, LLC1d78148a-586c-2f7d-e063-6294a90a46912024-07-17WarningsExact identifier
application number: M020
Derma E Sun Defense Face SPF 30ZINC OXIDE TITANIUM DIOXIDEderma ed90b8f81-de7a-4022-800a-90f063e941802024-07-17WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
application number: M020
CVS Beauty 360 7-in-1 Complete Daily Moisturizer Anti-Aging Formula with Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyfa412c9d-2a8b-bf71-e053-6394a90a8a632024-07-16WarningsExact identifier
application number: M020
CVS Health SPF 50 ClearAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECVS PHARMACYf42402ff-0d70-9231-e053-2995a90aa46d2024-07-16WarningsExact identifier
application number: M020
CVS Health Sunburn Relief CoolingLIDOCAINE HYDROCHLORIDECVS PHARMACY1d6402ea-4201-27f9-e063-6294a90a43f52024-07-16WarningsExact identifier
application number: M020
NYX Professional Makeup Blurscreen Primer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6ca01ccb-07f8-4d2c-84bb-6b251e73dad22024-07-16WarningsExact identifier
application number: M020
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8df98d97-a5d2-4d52-8bd2-130a13501d602024-07-16WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC1d4cab02-8897-6449-e063-6294a90ad72e2024-07-15WarningsExact identifier
application number: M020
the beach people SPF 50ZINC OXIDEThe Beach People United LLC2e5176e2-e2f4-4b08-8528-cb1ee3c166592024-07-15WarningsExact identifier
application number: M020
Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production23235897-c1fc-423f-99a2-e2ad282ee7442024-07-14WarningsExact identifier
application number: M020
LOreal Paris Bright Reveal Broad Spectrum SPF 50 Daily UV SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc96d72471-de95-4668-8903-aed6187633a92024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60TITANIUM DIOXIDECosmetique Active Productiona3b5dfe5-c726-4f9c-8e4d-0e9808480d4b2024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60TITANIUM DIOXIDELOreal USA Products Inc2e85cf6e-a2a7-4871-bdb6-1d72088c30312024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc664c67cc-7d63-45d7-abdd-157c041b0d3f2024-07-14WarningsExact identifier
application number: M020
SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDEL'Oreal USA Products Inc817c882d-72f3-4ee7-8da2-a4a32f9d167f2024-07-14WarningsExact identifier
application number: M020
Sun Wrangler Daily Mineral Sunscreen SPF 45ZINC OXIDESun Wrangler1d0e94f1-2996-c058-e063-6294a90a343b2024-07-12WarningsExact identifier
application number: M020
Derma E Sun Defense SPF 30ZINC OXIDE AND TITANIUM DIOXIDEderma e395b73a4-dae7-49da-9dab-ab622117c8c02024-07-12WarningsExact identifier
application number: M020
the beach people SPF 30ZINC OXIDEThe Beach People United LLC3a7cc69a-6027-4dfd-b9ef-9d4390fe630c2024-07-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-025-018295300250110 mL in 1 BOTTLE, PLASTIC (82953-025-01) 10 ml2024-05-30NoNoCurrent
82953-025-028295300250220 mL in 1 BOTTLE, PLASTIC (82953-025-02) 20 ml2024-05-30NoNoCurrent
82953-025-038295300250325 mL in 1 BOTTLE, PLASTIC (82953-025-03) 25 ml2024-05-30NoNoCurrent
82953-025-048295300250415 mL in 1 BOTTLE, PLASTIC (82953-025-04) 15 ml2024-05-30NoNoCurrent
82953-025-05829530025058 mL in 1 BOTTLE, PLASTIC (82953-025-05) 8 ml2024-05-30NoNoCurrent
82953-025-068295300250618 mL in 1 BOTTLE, PLASTIC (82953-025-06) 18 ml2024-05-30NoNoCurrent
82953-025-07829530025075 mL in 1 BOTTLE, PLASTIC (82953-025-07) 5 ml2024-05-30NoNoCurrent
82953-025-088295300250830 mL in 1 BOTTLE, PLASTIC (82953-025-08) 30 ml2024-05-30NoNoCurrent
82953-025-098295300250960 mL in 1 BOTTLE, PLASTIC (82953-025-09) 60 ml2024-05-30NoNoCurrent
82953-025-108295300251090 mL in 1 BOTTLE, PLASTIC (82953-025-10) 90 ml2024-05-30NoNoCurrent