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 227 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMMA LEWISHAM Sunceutical SPF 50 Mineral Glow SerumZINC OXIDE 20%EMMA LEWISHAM US, INC.2b097709-913f-d906-e063-6394a90a04462025-02-05WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Face CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2c703df8-23af-d630-e063-6294a90a1a242025-02-05WarningsExact identifier
application number: M020
doTERRA SunZINC OXIDEdoTERRA International, LLCdd308fef-e312-4ced-e053-2995a90a76fd2025-02-05WarningsExact identifier
application number: M020
OrgaPlus Ultra Pure Sun EX 15gOCTINOXATE, OCTISALATE, OCTOCRYLENEBLUEZONWIDE CO.,LTDb686ef63-7eee-4a4d-a559-417d8b09cc4f2025-02-05WarningsExact identifier
application number: M020
OrgaPlus Ultra Pure Sun EX 22gOCTINOXATE, OCTISALATE, OCTOCRYLENEBLUEZONWIDE CO.,LTDd3c422f6-a83d-48fc-94fc-2749666426c82025-02-05WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Body CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2d65b2d0-7013-d0ad-e063-6394a90ad4c22025-02-05WarningsExact identifier
application number: M020
Olay Sun Hydrating Facial Moisturizer with Sunscreen SPF 30 Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company2d6a6fed-a26e-e3a6-e063-6394a90ae2c72025-02-05WarningsExact identifier
application number: M020
Brush On Block Sheer Genius SPF 50 Mineral MoistureZINC OXIDESPF Ventures, LLC2d4b8c92-b932-89a7-e063-6394a90a621d2025-02-04WarningsExact identifier
application number: M020
Seven Thirty Daily Habit Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY30ca8f9d-b6a5-4af0-9d7b-487212e40e632025-02-03WarningsExact identifier
application number: M020
Atlanta Acne Specialist Everyday Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY3057f8ad-5850-49a0-b44d-3a1da84126e32025-02-03WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD.2d3faa43-0d78-58de-e063-6294a90a0b172025-02-03WarningsExact identifier
application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d40099a-2cfa-1d99-e063-6394a90a36a62025-02-03WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc Only-RefillZINC OXIDESPF Ventures, LLC2d47eb76-e644-4e04-e063-6294a90a93cc2025-02-03WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC2d490531-af36-87d0-e063-6394a90acf492025-02-03WarningsExact identifier
application number: M020
YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONESkin Ai, LLC2d8b7d07-2249-898b-e063-6394a90af6ad2025-02-01WarningsExact identifier
application number: M020
ESSENCE LIGHT SUNSCREEN SPF 50 PAAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.f5c79f1a-cecd-2409-e053-2995a90ad06f2025-01-31WarningsExact identifier
application number: M020
RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fields67b55df8-9623-4352-b136-b0bc8d1efe022025-01-31WarningsExact identifier
application number: M020
Oil-Free Daily Hydration SPF 15OCTINOXATE, AVOBENZONEBoscia LLCec322ae5-ab03-4c7b-9c6d-0bda3327c72a2025-01-31WarningsExact identifier
application number: M020
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEPaula's Choice, Incb90658d0-e422-4265-a6ee-39c29b6c116a2025-01-31WarningsExact identifier
application number: M020
SunStation USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact 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