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 87 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Loretta Universal Glow Daily Defense SPF 40ZINC OXIDEDr. Loretta, LLC1208d0f8-bb12-4574-b70e-3a76b11a64c72026-01-07WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKDC/One Development Corporation, Inc.259f3fe3-2967-6c05-e063-6394a90a9e452026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Extreme Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group4084dd98-357f-4011-b0d4-db6536d2931f2026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Extreme Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group9b4acc5e-fdaf-4fcb-83a9-69e430dd43de2026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Sensitive Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Groupb42261c5-fa6e-4bb3-93c0-97032ab9f7162026-01-07WarningsExact identifier
application number: M020
CabanaMilk Mineral Barrier Fluid SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD47d0fe4d-ad21-1004-e063-6394a90a9c192026-01-07WarningsExact identifier
application number: M020
CENTELLA RELIEF SOOTHING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEIUNIK Co., Ltd.47d170e3-dd76-d413-e063-6294a90ae8e42026-01-07WarningsExact identifier
application number: M020
Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad SpectrumZINC OXIDESEORIN COMPANY Co., Ltd.1e7cc417-3c57-c87c-e063-6394a90a670b2026-01-07WarningsExact identifier
application number: M020
Proactiv Clear Skin SPF 30AVOBENZONE, OCTISALATE, AND OCTOCRYLENEAlchemee, LLCb0aa7ff0-f712-486f-aaaf-f88fed3b5cd12026-01-07WarningsExact identifier
application number: M020
Daily Hydrating Mineral Body Sunscreen Broad Spectrum SPF 30 SunscreenZINC OXIDEOak Essentials, LLC47d37f44-10b2-214f-e063-6294a90a5abc2026-01-07WarningsExact identifier
application number: M020
PLUMSCREEN SPF 31ZINC OXIDELe Prunier Farms, Inc.e20eb996-2b64-6bd0-e053-2a95a90a4f922026-01-07WarningsExact identifier
application number: M020
BETA-GLUCAN MILD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEIUNIK Co., Ltd47d6ad8b-1081-ee21-e063-6294a90a0e632026-01-07WarningsExact identifier
application number: M020
Koobarra Mineral Face Sunscreen SPF 50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED37cf8143-99f2-cca5-e063-6394a90a19a82026-01-07WarningsExact identifier
application number: M020
Solar Swipe Mineral Sunscreen SPF50SOLAR SWIPE MINERAL SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd47d75d61-5295-3eab-e063-6394a90a01c12026-01-07WarningsExact identifier
application number: M020
LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREENZINC OXIDEJANE STREET LLCdbdd3e6a-f09d-90cf-e053-2a95a90a98a02026-01-07WarningsExact identifier
application number: M020
RENEWALUXE SPF 50 SunscreenRENEWALUXE SPF 50 SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd1bc29960-5e73-e8ab-e063-6294a90a3f802026-01-06WarningsExact identifier
application number: M020
ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREENSPF50Wild Child Laboratories PTY Ltd2767ba3e-7434-d474-e063-6294a90aa4ff2026-01-06WarningsExact identifier
application number: M020
ULTRA VIOLETTE SPF ON THE GLOW Duo Pack KitSPF 50Grace And Fire USA Inc.47b7da8a-ea89-1402-e063-6294a90a23f92026-01-06WarningsExact identifier
application number: M020
Hawaiian Blend Essential Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group5a6e622f-2c00-406a-8860-d7081656f5972026-01-06WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION66c22f17-5418-42ff-97b2-33fa10f5eac32026-01-06WarningsExact 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