FDA.reportPublic FDA data

SUNSCREEN

Product NDC
82953-017
11-digit product format
829530017
Labeler code
82953
Product ID
82953-017_2005d677-73da-b231-e063-6394a90a5b9a
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
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
19a7dc68-6384-3783-e063-6394a90ac839Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-017-01SUNSCREEN0115 mL in 1 BOTTLE, PLASTICCREAM152
82953-017-02SUNSCREEN0130 mL in 1 BOTTLE, PLASTICCREAM302
82953-017-03SUNSCREEN0160 mL in 1 BOTTLE, PLASTICCREAM602
82953-017-04SUNSCREEN0175 mL in 1 BOTTLE, PLASTICCREAM752
82953-017-05SUNSCREEN0135 mL in 1 BOTTLE, PLASTICCREAM352
82953-017-06SUNSCREEN0150 mL in 1 BOTTLE, PLASTICCREAM502
82953-017-07SUNSCREEN01120 mL in 1 BOTTLE, PLASTICCREAM1202
82953-017-08SUNSCREEN01240 mL in 1 BOTTLE, PLASTICCREAM2402
82953-017-09SUNSCREEN01300 mL in 1 BOTTLE, PLASTICCREAM3002
82953-017-10SUNSCREEN0190 mL in 1 BOTTLE, PLASTICCREAM902
82953-017-11SUNSCREEN0120 mL in 1 BOTTLE, PLASTICCREAM202
82953-017-12SUNSCREEN0145 mL in 1 BOTTLE, PLASTICCREAM452
82953-017-13SUNSCREEN011.5 mL in 1 POUCHCREAM1.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-017SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) CREAM [COSMUSES COSMETICS (NINGBO) CO., LTD.]2Current NDC, 13 package rows20240820_19a7dc68-6384-3783-e063-6394a90ac839.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 16 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair LightZINC OXIDEREJUVA MINERALS INC2abccc86-01d4-e45c-e063-6294a90a7f8b2026-07-02WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
application number: M020
Sunscreen SPF 50AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Productsf5e2a412-e891-411d-85da-89f38cd61a9b2026-07-02WarningsExact identifier
application number: M020
Bath and Body Works SPF Bronze KissAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.5606c57b-7fdb-4317-e063-6294a90a996c2026-07-02WarningsExact identifier
application number: M020
Evereden Kids Mineral Sunscreen SPF 30ZINC OXIDEEden Brands Incbba219a4-de83-76fd-e053-2995a90a2d692026-07-01WarningsExact identifier
application number: M020
Kids Mineral Face Cream SPF20ZINC OXIDEEden Brands Incfbfccb0c-e459-3282-e053-6394a90ad95d2026-07-01WarningsExact identifier
application number: M020
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50The Beach Roosterc2e57236-f184-4fa8-8fd5-c44cbf2300582026-07-01WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.557477a2-def8-740b-e063-6294a90ad2872026-06-30WarningsExact identifier
application number: M020
HealthyDerm tallow mineral sunscreen SPF50ZINC OXIDE 25%VIRENTIA LLC557b0b1f-8cd9-735a-e063-6294a90ad60e2026-06-30WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
application number: M020
Christian Dior Invisible UV Stick Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Dior8e3840b2-b404-474f-aff7-dec3a64a70a42026-06-29WarningsExact identifier
application number: M020
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
application number: M020
Sun Bum Coconut Lip 30 Sunscreen Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC20d942fa-93de-45a8-e063-6294a90a2b492026-06-29WarningsExact identifier
application number: M020
AVON ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDETHE AVON COMPANY54f7c1d1-acdb-fd25-e063-6294a90a81732026-06-29WarningsExact identifier
application number: M020
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.55364026-c55a-b370-e063-6294a90ae0d12026-06-27WarningsExact identifier
application number: M020
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
application number: M020
ORLASKIN HYDRATING SUNSCREEN SPF 50OCTOCRYLENE ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE AVOBENZONEGuangzhou Yapheon Health Industry Co., Ltd.552b4c87-4621-d5a7-e063-6294a90a042e2026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Waikiki Beach CoconutAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c30de8a-4d29-bbac-e063-6294a90a84d92026-06-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-017-018295300170115 mL in 1 BOTTLE, PLASTIC (82953-017-01) 15 ml2024-05-30NoNoCurrent
82953-017-028295300170230 mL in 1 BOTTLE, PLASTIC (82953-017-02) 30 ml2024-05-30NoNoCurrent
82953-017-038295300170360 mL in 1 BOTTLE, PLASTIC (82953-017-03) 60 ml2024-05-30NoNoCurrent
82953-017-048295300170475 mL in 1 BOTTLE, PLASTIC (82953-017-04) 75 ml2024-05-30NoNoCurrent
82953-017-058295300170535 mL in 1 BOTTLE, PLASTIC (82953-017-05) 35 ml2024-05-30NoNoCurrent
82953-017-068295300170650 mL in 1 BOTTLE, PLASTIC (82953-017-06) 50 ml2024-05-30NoNoCurrent
82953-017-0782953001707120 mL in 1 BOTTLE, PLASTIC (82953-017-07) 120 ml2024-05-30NoNoCurrent
82953-017-0882953001708240 mL in 1 BOTTLE, PLASTIC (82953-017-08) 240 ml2024-05-30NoNoCurrent
82953-017-0982953001709300 mL in 1 BOTTLE, PLASTIC (82953-017-09) 300 ml2024-05-30NoNoCurrent
82953-017-108295300171090 mL in 1 BOTTLE, PLASTIC (82953-017-10) 90 ml2024-05-30NoNoCurrent
82953-017-118295300171120 mL in 1 BOTTLE, PLASTIC (82953-017-11) 20 ml2024-05-30NoNoCurrent
82953-017-128295300171245 mL in 1 BOTTLE, PLASTIC (82953-017-12) 45 ml2024-05-30NoNoCurrent
82953-017-13829530017131.5 mL in 1 POUCH (82953-017-13) 1.5 ml2024-05-30NoNoCurrent