FDA.reportPublic FDA data

SUNSCREEN

Product NDC
82953-002
11-digit product format
829530002
Labeler code
82953
Product ID
82953-002_286c5fbb-74be-7de3-e063-6394a90a0973
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone,Homosalate,Octocrylene,Octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-26
Substance
OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE
Active strength
10; 10; 3; 5 g/100g; g/100g; g/100g; g/100g
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/100g
HOMOSALATE10 g/100g
AVOBENZONE3 g/100g
OCTISALATE5 g/100g

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
e98c3b64-edcb-16c7-e053-2a95a90a8a0eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-002-01SUNSCREEN0110 g in 1 BOTTLE, PLASTICCREAM104
82953-002-02SUNSCREEN0120 g in 1 BOTTLE, PLASTICCREAM204
82953-002-03SUNSCREEN0130 g in 1 BOTTLE, PLASTICCREAM304
82953-002-04SUNSCREEN0135 g in 1 BOTTLE, PLASTICCREAM354
82953-002-05SUNSCREEN0145 g in 1 BOTTLE, PLASTICCREAM454
82953-002-06SUNSCREEN0150 g in 1 BOTTLE, PLASTICCREAM504
82953-002-07SUNSCREEN0157 g in 1 BOTTLE, PLASTICCREAM574
82953-002-08SUNSCREEN011.5 g in 1 BOTTLE, PLASTICCREAM1.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-002SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) CREAM [COSMUSES COSMETICS (NINGBO) CO., LTD.]4Current NDC, Legacy NDC, 8 package rows20241206_e98c3b64-edcb-16c7-e053-2a95a90a8a0e.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 118 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eclipse Face TintedZINC OXIDEDENISE BELL SKIN CARE396f0151-2d0d-f4da-e063-6394a90a5f7f2025-12-15Exact identifier
application number: M020
Eclipse Body Non TintedZINC OXIDEDENISE BELL SKIN CARE396f56df-d0de-1344-e063-6294a90a46ea2025-12-15Exact identifier
application number: M020
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
application number: M020
Sun Veil Illuminating Sunscreen SPF30ZINC OXIDEKoco Life LLC46001097-540e-65da-e063-6294a90af2992025-12-15WarningsExact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
application number: M020
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC3544916b-3f63-3a7a-e063-6394a90ae5072025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC3545d603-3d01-c51d-e063-6394a90a15992025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC357efafb-aa1c-0d69-e063-6394a90a51352025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC35806102-6919-116f-e063-6294a90ad9222025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f915a-bd77-350b-e063-6294a90ad27f2025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY35805e66-18e6-0e45-e063-6294a90afe582025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35474ac4-8a9d-6a84-e063-6394a90a9bad2025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER357e315e-8802-ad73-e063-6394a90a24952025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82953-002-018295300020110 g in 1 BOTTLE, PLASTIC (82953-002-01) 10 g2022-09-260000-00-00NoNoCurrent
82953-002-028295300020220 g in 1 BOTTLE, PLASTIC (82953-002-02) 20 g2022-09-260000-00-00NoNoCurrent
82953-002-038295300020330 g in 1 BOTTLE, PLASTIC (82953-002-03) 30 g2022-09-260000-00-00NoNoCurrent
82953-002-048295300020435 g in 1 BOTTLE, PLASTIC (82953-002-04) 35 g2022-09-260000-00-00NoNoCurrent
82953-002-058295300020545 g in 1 BOTTLE, PLASTIC (82953-002-05) 45 g2022-09-260000-00-00NoNoCurrent
82953-002-068295300020650 g in 1 BOTTLE, PLASTIC (82953-002-06) 50 g2022-09-260000-00-00NoNoCurrent
82953-002-078295300020757 g in 1 BOTTLE, PLASTIC (82953-002-07) 57 g2022-09-26NoNoCurrent
82953-002-08829530002081.5 g in 1 BOTTLE, PLASTIC (82953-002-08) 1.5 g2022-09-26NoNoCurrent