FDA.reportPublic FDA data

SUNSCREEN

Product NDC
82953-023
11-digit product format
829530023
Labeler code
82953
Product ID
82953-023_202ea60a-5a91-2b37-e063-6394a90a66df
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone,Homosalate,Octocrylene,Octisalate
Dosage form
LOTION
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
202e99ef-330e-ad94-e063-6294a90a2d2aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-023-01SUNSCREEN0115 mL in 1 BOTTLE, PLASTICLOTION151
82953-023-02SUNSCREEN0130 mL in 1 BOTTLE, PLASTICLOTION301
82953-023-03SUNSCREEN0160 mL in 1 BOTTLE, PLASTICLOTION601
82953-023-04SUNSCREEN0175 mL in 1 BOTTLE, PLASTICLOTION751
82953-023-05SUNSCREEN0135 mL in 1 BOTTLE, PLASTICLOTION351
82953-023-06SUNSCREEN0150 mL in 1 BOTTLE, PLASTICLOTION501
82953-023-07SUNSCREEN01120 mL in 1 BOTTLE, PLASTICLOTION1201
82953-023-08SUNSCREEN01240 mL in 1 BOTTLE, PLASTICLOTION2401
82953-023-09SUNSCREEN01300 mL in 1 BOTTLE, PLASTICLOTION3001
82953-023-10SUNSCREEN0190 mL in 1 BOTTLE, PLASTICLOTION901
82953-023-11SUNSCREEN0120 mL in 1 BOTTLE, PLASTICLOTION201
82953-023-12SUNSCREEN0145 mL in 1 BOTTLE, PLASTICLOTION451
82953-023-13SUNSCREEN011.5 mL in 1 POUCHLOTION1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-023SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) LOTION [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 13 package rows20240822_202e99ef-330e-ad94-e063-6294a90a2d2a.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 90 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTEROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION0a214b6b-69a7-4cb9-9095-6fcf2b6945de2026-01-05WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfb6ac681-ff74-4420-a4f6-843d5f2b6d6b2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION207e2035-5f31-4745-a801-b386b040b7382026-01-05WarningsExact identifier
application number: M020
Hawaiian Blend Essential Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group47aa8605-e536-b998-e063-6394a90ad9f02026-01-05WarningsExact identifier
application number: M020
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbf736c5b-fc33-4cd5-8d18-03929f739d762026-01-05WarningsExact identifier
application number: M020
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 1OCTINOXATESHISEIDO AMERICAS CORPORATION8a9294c2-3933-4f9c-b7e6-1f446f441a162026-01-05WarningsExact identifier
application number: M020
Shiseido Future Solution LX Total ProtectiveAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION6de17911-4bce-46c9-906b-07d899a36ceb2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc4028089-677f-4d51-9c8b-3892ff1649e02026-01-05WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION8a0da327-a805-4ef9-b69a-14bf7278a81a2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE CORRECTING VEIL nENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfd9b42e4-6f9d-45a9-bee3-ac1bc4b352522026-01-05WarningsExact identifier
application number: M020
SHISEIDO THE MAKEUP FOUNDATION I20TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION3c024fe9-2983-4857-a55a-13406158e3a92026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONb2b55a7a-1f68-429d-ba70-5bb6c7e0d8d32026-01-05WarningsExact identifier
application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMYZINC OXIDEKao USA Inc.26bcb9cd-bfb5-998c-e063-6394a90ab9d62026-01-05WarningsExact identifier
application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUDZINC OXIDEKao USA Inc.26cf1320-aae5-2ea0-e063-6394a90a3be22026-01-05WarningsExact identifier
application number: M020
OZE SUN BONDIZINC OXIDE SUNSCREENVEGANIC SKN LIMITED47b1aae6-0b86-7d48-e063-6294a90a9ece2026-01-05WarningsExact identifier
application number: M020
Hybrid SPF SPF 30OCTOCRYLENE, OCTISALATE, ZINC OXIDETopiderm, Inc.5c99f98c-025c-4886-824f-af968033baf42026-01-05WarningsExact identifier
application number: M020
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 PlusTITANIUM DIOXIDEHEY HONEY INC.21187805-fae9-476c-81b0-27ffeb0b99112026-01-05WarningsExact identifier
application number: M020
VEAKSON BEEF TALLOW SUNSCREENZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACIDGuangdong Aimu Biological Technology Co., Ltd473c241a-1258-1680-e063-6394a90a7d982026-01-04WarningsExact identifier
application number: M020
HYDRATING SUNSCREENHYDRATING SUNSCREENGuangzhou Yapeng Refinement Chemical Co., Ltd.19a3687b-32b0-7c83-e063-6294a90aaf812026-01-04WarningsExact identifier
application number: M020
Bellas Friends Sunscreen StickZINC OXIDEPanergytek Usa Inc478cbdeb-28e4-fa56-e063-6294a90af1242026-01-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-023-018295300230115 mL in 1 BOTTLE, PLASTIC (82953-023-01) 15 ml2024-05-30NoNoCurrent
82953-023-028295300230230 mL in 1 BOTTLE, PLASTIC (82953-023-02) 30 ml2024-05-30NoNoCurrent
82953-023-038295300230360 mL in 1 BOTTLE, PLASTIC (82953-023-03) 60 ml2024-05-30NoNoCurrent
82953-023-048295300230475 mL in 1 BOTTLE, PLASTIC (82953-023-04) 75 ml2024-05-30NoNoCurrent
82953-023-058295300230535 mL in 1 BOTTLE, PLASTIC (82953-023-05) 35 ml2024-05-30NoNoCurrent
82953-023-068295300230650 mL in 1 BOTTLE, PLASTIC (82953-023-06) 50 ml2024-05-30NoNoCurrent
82953-023-0782953002307120 mL in 1 BOTTLE, PLASTIC (82953-023-07) 120 ml2024-05-30NoNoCurrent
82953-023-0882953002308240 mL in 1 BOTTLE, PLASTIC (82953-023-08) 240 ml2024-05-30NoNoCurrent
82953-023-0982953002309300 mL in 1 BOTTLE, PLASTIC (82953-023-09) 300 ml2024-05-30NoNoCurrent
82953-023-108295300231090 mL in 1 BOTTLE, PLASTIC (82953-023-10) 90 ml2024-05-30NoNoCurrent
82953-023-118295300231120 mL in 1 BOTTLE, PLASTIC (82953-023-11) 20 ml2024-05-30NoNoCurrent
82953-023-128295300231245 mL in 1 BOTTLE, PLASTIC (82953-023-12) 45 ml2024-05-30NoNoCurrent
82953-023-13829530023131.5 mL in 1 POUCH (82953-023-13) 1.5 ml2024-05-30NoNoCurrent