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 42 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.6a48ad0d-20e4-44b1-90d6-30bfbc68a1522026-04-17WarningsExact identifier
application number: M020
Pacto Refreshing Sunscreen Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEMynd LLC56ad7c97-3dae-4bac-a677-f5052dfdfea42026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f95cd0a-f996-648b-e063-6294a90adc282026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f968058-e851-86d0-e063-6294a90aa7862026-04-16WarningsExact identifier
application number: M020
Red Cherry SPF 15 Broad Spectrum Lip BalmRED CHERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc4f96d057-39b8-e4d5-e063-6394a90acb5c2026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Fair-LightZINC OXIDEZO Skin Health, Inc.4f9988a0-ae4a-9940-e063-6294a90ad91d2026-04-16WarningsExact identifier
application number: M020
MELAO Hydrating Mineral SunscreenTITANIUM DIOXIDE,ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4f778eb0-55f7-38d0-e063-6394a90a69a02026-04-15WarningsExact identifier
application number: M020
Tanning Club Everyday Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONETANNING CLUB, LLC75820400-a5e0-4cf5-8b4f-a52500ce62c32026-04-15WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f8353b3-4ac1-9703-e063-6294a90abdad2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f83dd76-a8d8-916e-e063-6294a90ab6ed2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick - TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f84619f-3415-7443-e063-6394a90a162a2026-04-15WarningsExact identifier
application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDEPML NYC, LLC1be639a8-179a-7015-e063-6394a90ab64b2026-04-15WarningsExact identifier
application number: M020
PHELITYL DAY SPF 15PHELITYL DAY SPF 15PML NYC, LLCea9d33d9-6f9f-0a66-e053-2a95a90abd422026-04-15WarningsExact identifier
application number: M020
FIRMARINE MOISTURIZER SPF 30FIRMARINE MOISTURIZER SPF 30PML NYC, LLCea9db179-1b69-01e0-e053-2a95a90a16282026-04-15WarningsExact identifier
application number: M020
EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15PML NYC, LLCeaa562b1-3fc6-1a85-e053-2995a90ad1ec2026-04-15WarningsExact identifier
application number: M020
DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30PML NYC, LLCea90bb4d-6f4a-45c9-e053-2a95a90a53a72026-04-15WarningsExact identifier
application number: M020
RICH GIRL HAND SPF 25RICH GIRL HANDPML NYC, LLCea8f4421-109f-41a5-e053-2a95a90a38322026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTERYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e24a63e-d76f-6581-e063-6394a90a61812026-04-15WarningsExact identifier
application number: M020
JAFRA SUN Facial Sunscreen COLOR MATCH BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.cf33c5a1-b7c5-4c5a-9981-e4e24208cd112026-04-15WarningsExact identifier
application number: M020
JAFRA SUN Facial Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.56c124d7-0b8c-4bb9-8261-c7395353fbe02026-04-15WarningsExact 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