FDA.reportPublic FDA data

sunscreen

Product NDC
82953-003
11-digit product format
829530003
Labeler code
82953
Product ID
82953-003_286c802e-e0fb-9b20-e063-6394a90a504a
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
2022-09-30
Substance
HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
10; 10; 5; 3 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
HOMOSALATE10 g/100mL
OCTOCRYLENE10 g/100mL
OCTISALATE5 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-003-01sunscreen0110 mL in 1 BOTTLE, PLASTICSPRAY103
82953-003-02sunscreen015 mL in 1 BOTTLE, PLASTICSPRAY53
82953-003-03sunscreen0120 mL in 1 BOTTLE, PLASTICSPRAY203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-003SUNSCREEN 01 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) SPRAY [COSMUSES COSMETICS (NINGBO) CO., LTD.]3Current NDC, Legacy NDC, 3 package rows20241206_e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f8.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 126 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Skin Shield PlusZINC OXIDELAURA CATHERINE, LLC36e9958b-cc5c-f7ff-e063-6394a90ac80d2025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer MatteTITANIUM DIOXIDE, ZINC OXIDESimply Bare Waxing & Skin Care LLC36d8e8ba-a3dd-257d-e063-6294a90a30d62025-12-15Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e9e8d7-3fcf-1e94-e063-6394a90a8dc62025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer CPlusE GlowZINC OXIDESimply Bare Waxing & Skin Care LLC36d968df-5168-61bf-e063-6294a90a94b72025-12-15Exact identifier
application number: M020
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d45b48-e08d-ef40-e063-6394a90a635c2025-12-15Exact identifier
application number: M020
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d439fb-b9cf-2774-e063-6294a90ae8852025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer CPlusE GlowZINC OXIDESimply Bare Waxing & Skin Care LLC36d9b48d-e3db-6ae2-e063-6294a90abbf52025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer MatteTITANIUM DIOXIDE, ZINC OXIDESimply Bare Waxing & Skin Care LLC36d9d83b-7da7-a006-e063-6394a90a9d842025-12-15Exact identifier
application number: M020
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN & ACNE36d3ebc0-1de6-1998-e063-6294a90a02e62025-12-15Exact identifier
application number: M020
Sun Safe Lip BalmTITANIUM DIOXIDE, ZINC OXIDEREVIVE IN SOLANO36c4f0c9-5789-ca58-e063-6394a90a23232025-12-15Exact identifier
application number: M020
Titanium Dioxide, Zinc OxideON THE GO SUNSCREEN STICKREVIVE IN SOLANO36c57e6f-c747-9926-e063-6294a90a57212025-12-15Exact identifier
application number: M020
Daily Shade Dewy Glow TintedZINC OXIDEBLISS BEAUTY LLC373babab-2949-5474-e063-6394a90aacd72025-12-15Exact identifier
application number: M020
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC3739bdb8-2152-b2ba-e063-6294a90acd942025-12-15Exact identifier
application number: M020
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC37396a51-225d-7669-e063-6294a90af6d32025-12-15Exact identifier
application number: M020
Daily Shade Dewy Glow TintedZINC OXIDEBLISS BEAUTY LLC373a4c37-e280-bacb-e063-6394a90a5af82025-12-15Exact identifier
application number: M020
Daily Shade Sheer MatteZINC OXIDEBLISS BEAUTY LLC373a0d67-b225-ecb0-e063-6294a90a9ac12025-12-15Exact identifier
application number: M020
Daily Shade Sheer MatteZINC OXIDEBLISS BEAUTY LLC373b3e56-f923-dd24-e063-6294a90acf532025-12-15Exact identifier
application number: M020
Tinted Lip Shade SunscreenTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC373a7c01-ba9f-4b00-e063-6294a90ae1a22025-12-15Exact identifier
application number: M020
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC373b7ab9-c692-fc1b-e063-6294a90aa8032025-12-15Exact identifier
application number: M020
Antioxidant Mineral Sunscreen Plus Primer Lightly TintedZINC OXIDETrue Beauty Brows & Skin Care37dc4599-bd97-8c85-e063-6294a90ad1dc2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82953-003-018295300030110 mL in 1 BOTTLE, PLASTIC (82953-003-01) 10 ml2022-09-300000-00-00NoNoCurrent
82953-003-02829530003025 mL in 1 BOTTLE, PLASTIC (82953-003-02) 5 ml2022-09-300000-00-00NoNoCurrent
82953-003-038295300030320 mL in 1 BOTTLE, PLASTIC (82953-003-03) 20 ml2022-09-300000-00-00NoNoCurrent