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 86 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
application number: M020
RODAN and FIELDS ENHANCEMENTS MEDIUMTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC6aa6ad3f-2c52-4031-9e6c-7526c42de71d2026-01-09WarningsExact identifier
application number: M020
FACE SPF 47 SETTINGFACE SPF 47 SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47db9a54-c02f-d2ea-e063-6394a90ab9732026-01-08WarningsExact identifier
application number: M020
BADABOOM SUNSCREENSUNSCREENAopline Biotechnology (Guangzhou) Co., Ltd.47dbf363-2892-4530-e063-6294a90abe1f2026-01-08WarningsExact identifier
application number: M020
ROE WELLNESS SPF 50 MINERALSPF 50 MINERAL POWDERAopline Biotechnology (Guangzhou) Co., Ltd.47dc8155-4abb-4bb7-e063-6294a90af1ad2026-01-08WarningsExact identifier
application number: M020
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
application number: M020
SUNSCREEN SETTING SPRITZ, SPF 45SUNSCREEN SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47ddf752-cae2-313f-e063-6294a90a7e3a2026-01-08WarningsExact identifier
application number: M020
St Moriz suncare face sunscreen spf50OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df072e-151f-eb30-e063-6294a90a4eeb2026-01-08WarningsExact identifier
application number: M020
SUNSCREEN GLOWINGAVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df0de5-012a-c896-e063-6394a90a9cef2026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35f6-63d2-3d26-e053-2991aa0a5b442026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35a1-a139-1974-e053-2a91aa0a20b62026-01-08WarningsExact identifier
application number: M020
PIPA SKIN CARE SUN-SATIONAL Mineral SunscreenSPF 30EVI LABS258b7b7c-a3f2-172c-e063-6394a90aec6a2026-01-08WarningsExact identifier
application number: M020
DMK Ultrascreen Mineral SunscreenZINC OXIDEDanne Montague King3f022275-c1e5-2704-e063-6294a90a4a812026-01-08WarningsExact identifier
application number: M020
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 SheerREJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEERAtlantic Medical Products, LLC47e5198e-7bf6-72a8-e063-6294a90a7ec52026-01-08WarningsExact identifier
application number: M020
inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUMINDE WILD SUN DEFENSE GLOW DROPSINDE WILD PRIVATE LIMITED47e57407-2925-09ca-e063-6294a90a49ec2026-01-08WarningsExact identifier
application number: M020
NIDA Invisible Fit SunscreenSUNSCREENProso Corp47ed3b62-45ef-b67a-e063-6294a90a317b2026-01-08WarningsExact identifier
application number: M020
Organic Matters SPF 50 SunscreenZINC OXIDEVeganic SKN Limited12f37c8d-07f0-3e75-e063-6294a90a2cdf2026-01-08WarningsExact identifier
application number: M020
Ellegreen Sunscreen Broad Spectrum SPF50ZINC OXIDEVeganic SKN Limited161a7209-10d8-928c-e063-6394a90a41392026-01-08WarningsExact identifier
application number: M020
Live Sunny Eco-zinc hydrating mineral sunscreen for body and faceZINC OXIDEVeganic SKN Limited1a97169e-67be-3d25-e063-6294a90a3b882026-01-08WarningsExact 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