FDA.reportPublic FDA data

SUNSCREEN

Product NDC
82953-025
11-digit product format
829530025
Labeler code
82953
Product ID
82953-025_229d8002-259a-f252-e063-6394a90adda1
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
229dabbc-9043-3c9d-e063-6394a90a5692Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-025-01SUNSCREEN0110 mL in 1 BOTTLE, PLASTICSPRAY101
82953-025-02SUNSCREEN0120 mL in 1 BOTTLE, PLASTICSPRAY201
82953-025-03SUNSCREEN0125 mL in 1 BOTTLE, PLASTICSPRAY251
82953-025-04SUNSCREEN0115 mL in 1 BOTTLE, PLASTICSPRAY151
82953-025-05SUNSCREEN018 mL in 1 BOTTLE, PLASTICSPRAY81
82953-025-06SUNSCREEN0118 mL in 1 BOTTLE, PLASTICSPRAY181
82953-025-07SUNSCREEN015 mL in 1 BOTTLE, PLASTICSPRAY51
82953-025-08SUNSCREEN0130 mL in 1 BOTTLE, PLASTICSPRAY301
82953-025-09SUNSCREEN0160 mL in 1 BOTTLE, PLASTICSPRAY601
82953-025-10SUNSCREEN0190 mL in 1 BOTTLE, PLASTICSPRAY901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-025SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) SPRAY [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 10 package rows20240922_229dabbc-9043-3c9d-e063-6394a90a5692.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 195 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum 50 Premium Moisturizing Sunscreen Roll-OnAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c58c9c7-ca9e-d012-e063-6394a90a5aa92025-08-14WarningsExact identifier
application number: M020
Sun Bum 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a003d82-90bd-f541-e063-6394a90ac9062025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a00e4fb-6bf2-4c44-e063-6294a90a61bf2025-08-14WarningsExact identifier
application number: M020
Sun Bum 15 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a0f99df-e6c0-71d9-e063-6294a90a4c9e2025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Mineral SunscreenZINC OXIDESun Bum, LLC3a13d4f1-c158-7fa0-e063-6294a90a6fb42025-08-14WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear Sunscreen Face StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a147fe1-0dda-5433-e063-6394a90a1a592025-08-14WarningsExact identifier
application number: M020
Sun Bum 15 Premium Sunscreen BrowningAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c5b0db8-f05a-2b5c-e063-6294a90ae79b2025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3aaf7d28-b306-b416-e063-6294a90a021e2025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a263b85-e7a0-c068-e063-6294a90a49f22025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Mineral Sunscreen Roll-OnTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a392237-019d-2384-e063-6394a90a5b242025-08-14WarningsExact identifier
application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - BonfireHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3a3b3b4a-148c-1dc5-e063-6394a90a7bdb2025-08-14WarningsExact identifier
application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude BeachHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3ac48eef-f651-af96-e063-6294a90a501e2025-08-14WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NV6a398dad-2fb9-4cdb-86c5-2a392b88f29b2025-08-13WarningsExact identifier
application number: M020
SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40ZINC OXIDEALL THE RAJE, LLC9ffbd53b-1295-42b4-9cd5-18cbb75921d02025-08-13WarningsExact identifier
application number: M020
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, BistreZINC OXIDEPower Beauty Co.2e6eac42-0b70-44ea-e063-6294a90a49f82025-08-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c414e9b-6c3e-2c8d-e063-6394a90af4a62025-08-13WarningsExact identifier
application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40ZINC OXIDEEleeo Brands LLC3c443347-0134-8c87-e063-6294a90a80462025-08-13WarningsExact identifier
application number: M020
Earth Mama Baby Face Mineral Sunscreen Stick SPF 40ZINC OXIDEEleeo Brands LLC3a22f0b9-2d6d-6230-e063-6294a90adf312025-08-13WarningsExact identifier
application number: M020
Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40ZINC OXIDEEleeo Brands LLC3c4567d6-879e-f995-e063-6394a90a319f2025-08-13WarningsExact identifier
application number: M020
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c457455-b9b1-546b-e063-6294a90a41f62025-08-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-025-018295300250110 mL in 1 BOTTLE, PLASTIC (82953-025-01) 10 ml2024-05-30NoNoCurrent
82953-025-028295300250220 mL in 1 BOTTLE, PLASTIC (82953-025-02) 20 ml2024-05-30NoNoCurrent
82953-025-038295300250325 mL in 1 BOTTLE, PLASTIC (82953-025-03) 25 ml2024-05-30NoNoCurrent
82953-025-048295300250415 mL in 1 BOTTLE, PLASTIC (82953-025-04) 15 ml2024-05-30NoNoCurrent
82953-025-05829530025058 mL in 1 BOTTLE, PLASTIC (82953-025-05) 8 ml2024-05-30NoNoCurrent
82953-025-068295300250618 mL in 1 BOTTLE, PLASTIC (82953-025-06) 18 ml2024-05-30NoNoCurrent
82953-025-07829530025075 mL in 1 BOTTLE, PLASTIC (82953-025-07) 5 ml2024-05-30NoNoCurrent
82953-025-088295300250830 mL in 1 BOTTLE, PLASTIC (82953-025-08) 30 ml2024-05-30NoNoCurrent
82953-025-098295300250960 mL in 1 BOTTLE, PLASTIC (82953-025-09) 60 ml2024-05-30NoNoCurrent
82953-025-108295300251090 mL in 1 BOTTLE, PLASTIC (82953-025-10) 90 ml2024-05-30NoNoCurrent