FDA.reportPublic FDA data

SUNSCREEN

Product NDC
82953-018
11-digit product format
829530018
Labeler code
82953
Product ID
82953-018_1c413199-63dd-9141-e063-6294a90a796b
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
19a8f5d5-d3c7-4a6f-e063-6294a90a94e3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-018-01SUNSCREEN0110 mL in 1 BOTTLE, PLASTICSPRAY102
82953-018-02SUNSCREEN0120 mL in 1 BOTTLE, PLASTICSPRAY202
82953-018-03SUNSCREEN0125 mL in 1 BOTTLE, PLASTICSPRAY252
82953-018-04SUNSCREEN0115 mL in 1 BOTTLE, PLASTICSPRAY152
82953-018-05SUNSCREEN018 mL in 1 BOTTLE, PLASTICSPRAY82
82953-018-06SUNSCREEN0118 mL in 1 BOTTLE, PLASTICSPRAY182
82953-018-07SUNSCREEN015 mL in 1 BOTTLE, PLASTICSPRAY52
82953-018-08SUNSCREEN0130 mL in 1 BOTTLE, PLASTICSPRAY302
82953-018-09SUNSCREEN0160 mL in 1 BOTTLE, PLASTICSPRAY602
82953-018-10SUNSCREEN0190 mL in 1 BOTTLE, PLASTICSPRAY902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-018SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) SPRAY [COSMUSES COSMETICS (NINGBO) CO., LTD.]2Current NDC, 10 package rows20240704_19a8f5d5-d3c7-4a6f-e063-6294a90a94e3.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 145 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfecting Blendrops Broad Spectrum SPF 40HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC12512cac-652e-b138-e063-6394a90ad1f22025-12-09WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEASHLEY SAMAI38f457fa-0e95-7298-e063-6394a90adda82025-12-09Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEOLGA KLIMOV INC387b41a4-057f-88af-e063-6394a90adbbe2025-12-09Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEOLGA KLIMOV INC387b8ae6-c48b-905c-e063-6394a90a31fb2025-12-09Exact identifier
application number: M020
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS36ea709b-3536-5052-e063-6394a90a48f92025-12-09Exact identifier
application number: M020
Age Defying Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b028159-f240-2cf2-e063-6294a90a32b52025-12-09WarningsExact identifier
application number: M020
Ultimate Mineral ProtectionZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b02bf69-b648-56e1-e063-6294a90aeef32025-12-09WarningsExact identifier
application number: M020
G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.01dcfd14-7a1d-98fa-e063-6294a90a03362025-12-09WarningsExact identifier
application number: M020
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS3aff2074-1514-b5c5-e063-6394a90a75722025-12-09Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER3729d270-64ac-4d2e-e063-6294a90aeb2c2025-12-09Exact identifier
application number: M020
Non Tinted Replenishing Daily ProtectionZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER372a41f6-40f6-4971-e063-6394a90a83e02025-12-09Exact identifier
application number: M020
Stay Shady Non-Tinted Mineral SunscreenZINC OXIDEAMOIE ALAYVILLA3b277237-3a2e-1fb0-e063-6294a90adf202025-12-09WarningsExact identifier
application number: M020
Stay Shady Non-Tinted Mineral SunscreenZINC OXIDEAMOIE ALAYVILLA3b27225f-4589-d915-e063-6294a90a72252025-12-09WarningsExact identifier
application number: M020
Replenishing Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC3738a0c3-5c07-e49b-e063-6394a90a38e92025-12-09Exact identifier
application number: M020
Replenishing Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC37385fc6-1cde-8aa6-e063-6294a90a60172025-12-09Exact identifier
application number: M020
Replenishing Tinted SunscreenZINC OXIDEBeauty Journey Studio LLC3738e5e0-f6d9-0568-e063-6294a90a67b62025-12-09Exact identifier
application number: M020
JAYSUING Matte Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456b44da-02f3-93a0-e063-6294a90a8d062025-12-08WarningsExact identifier
application number: M020
JAYSUING Matte Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456c2974-d499-7841-e063-6294a90a98eb2025-12-08WarningsExact identifier
application number: M020
JAYSUING Ginseng Moist Sun SerumTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456cfa70-f524-f5cb-e063-6394a90ae7dc2025-12-08WarningsExact identifier
application number: M020
Face and Body SunscreenNON-NANO ZINC OXIDE 25%Guangzhou Shengyanghui Industrial Trading Co., Ltd3ee96538-06e8-75b1-e063-6394a90a52852025-12-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-018-018295300180110 mL in 1 BOTTLE, PLASTIC (82953-018-01) 10 ml2024-05-30NoNoCurrent
82953-018-028295300180220 mL in 1 BOTTLE, PLASTIC (82953-018-02) 20 ml2024-05-30NoNoCurrent
82953-018-038295300180325 mL in 1 BOTTLE, PLASTIC (82953-018-03) 25 ml2024-05-30NoNoCurrent
82953-018-048295300180415 mL in 1 BOTTLE, PLASTIC (82953-018-04) 15 ml2024-05-30NoNoCurrent
82953-018-05829530018058 mL in 1 BOTTLE, PLASTIC (82953-018-05) 8 ml2024-05-30NoNoCurrent
82953-018-068295300180618 mL in 1 BOTTLE, PLASTIC (82953-018-06) 18 ml2024-05-30NoNoCurrent
82953-018-07829530018075 mL in 1 BOTTLE, PLASTIC (82953-018-07) 5 ml2024-05-30NoNoCurrent
82953-018-088295300180830 mL in 1 BOTTLE, PLASTIC (82953-018-08) 30 ml2024-05-30NoNoCurrent
82953-018-098295300180960 mL in 1 BOTTLE, PLASTIC (82953-018-09) 60 ml2024-05-30NoNoCurrent
82953-018-108295300181090 mL in 1 BOTTLE, PLASTIC (82953-018-10) 90 ml2024-05-30NoNoCurrent