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 168 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCdd9ebc46-0fa4-5d96-e053-2995a90a79182025-11-06WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCeeb3c173-b280-76e4-e053-2995a90a0e792025-11-06WarningsExact identifier
application number: M020
SPF 50 Sunscreen StickZINC OXIDEELEEO BRANDS LLC09cf0f04-961e-4430-91bb-224e7fed13ef2025-11-06WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCefcd52c2-4208-46a1-e053-2a95a90a857d2025-11-06WarningsExact identifier
application number: M020
Peachy Mineral Facial SunscreenZINC OXIDEPeachy Corp42efead0-0e11-7270-e063-6394a90a4eb92025-11-06WarningsExact identifier
application number: M020
Peachy Tinted Facial SunscreenZINC OXIDEPeachy Corp42f0fb68-c0bf-cf98-e063-6294a90ab7032025-11-06WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands, LLC764401f3-4219-6e9b-e053-2991aa0a3ed22025-11-06WarningsExact identifier
application number: M020
Banana Boat Sport coolzone Clear Sunscreen Broad Spectrum SPF 30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCab7102ba-1020-3f51-e053-2995a90ae24d2025-11-06WarningsExact identifier
application number: M020
Banana Boat Sunscreen Lip Balm UVA/UVB Broad Spectrum SPF 45AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc794592c-d24e-4530-e053-2995a90a7e4d2025-11-06WarningsExact identifier
application number: M020
Green Envee Radiance SheerZINC OXIDEGreen Envee42f1908f-2787-c4e5-e063-6294a90afcd02025-11-06WarningsExact identifier
application number: M020
Indie Lee Daily PrimerZINC OXIDEAmerica Exchange38e5232b-7daf-7e61-e063-6394a90aa5b02025-11-06WarningsExact identifier
application number: M020
Duette UntintedZINC OXIDESkin Theory Studios3ce24b39-8bb1-1246-e063-6294a90a32d42025-11-06WarningsExact identifier
application number: M020
Duette TintedZINC OXIDESkin Theory Studios3ce1d7cb-b37d-fb9f-e063-6394a90aaef32025-11-06WarningsExact identifier
application number: M020
Truskin Broad Spectrum Mineral Sunscreen Facial Serum with Vitamin C and AloeZINC OXIDEAllure Labs42f3999f-4163-fadc-e063-6294a90aacf32025-11-06WarningsExact identifier
application number: M020
Melan RXZINC OXIDEMelan RXf4bdf20c-b6bc-55f1-e053-2995a90ac3082025-11-06WarningsExact identifier
application number: M020
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDe1eb77f1-d65c-4af8-a7d9-90f10570960f2025-11-06WarningsExact identifier
application number: M020
Ultraceuticals Ultra UV Protective Daily MoisturisingZINC OXIDEUltraceuticalsfc8a5c02-23b4-b4d8-e053-6294a90a55ea2025-11-06WarningsExact identifier
application number: M020
Vaihea Protect Clean SPF DropsZINC OXIDEVaihea Skincare LLCfe7e3145-a8e2-d14f-e053-6394a90abb5e2025-11-06WarningsExact identifier
application number: M020
Refy Skin TrioZINC OXIDERefy3029a690-dbb0-ff15-e063-6394a90abdbe2025-11-06WarningsExact identifier
application number: M020
Stream2Sea Broad Spectrum 20TITANIUM DIOXIDEStream2Sea, LLC1775d07d-6914-6928-e054-00144ff88e882025-11-06WarningsExact 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