FDA.reportPublic FDA data

sunscreen

Product NDC
87357-001
11-digit product format
873570001
Labeler code
87357
Product ID
87357-001_48f13b1c-8105-881b-e063-6394a90a816d
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
LOTION
Route
CUTANEOUS
Labeler
Guangdong Zhoubang Biotechnology Co., Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-22
Substance
TITANIUM DIOXIDE; ETHYLHEXYL SALICYLATE
Active strength
2.85; 3 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE2.85 g/100mL
ETHYLHEXYL SALICYLATE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal 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
48f13b1c-8104-881b-e063-6394a90a816dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87357-001-01sunscreen30 mL in 1 BOTTLE, GLASSLOTION301

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 298 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intensive Age Defying Hydrating Complex SPF 25HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONEJune Jacobs Labs, LLC18f59d9d-1328-d815-e063-6294a90a38012024-05-21WarningsExact identifier
application number: M020
Advanced Sun Resistance SPF 30HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONEJune Jacobs Labs, LLC18f879f0-3d5b-0067-e063-6394a90a9db32024-05-21WarningsExact identifier
application number: M020
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs LLC18e1edd9-e39b-c91f-e063-6394a90a32a02024-05-20WarningsExact identifier
application number: M020
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs, LLC18e4c50d-eb91-c269-e063-6394a90a79992024-05-20WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Tropical SunscreenBROAD SPECTRUM SPF 30 TROPICAL SUNSCREENRaining Rose, Inc18e7fc6b-b40a-f790-e063-6294a90ad0f42024-05-20WarningsExact identifier
application number: M020
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEAllure Labs18aa2604-c8f0-ca04-e063-6294a90a1c252024-05-17WarningsExact identifier
application number: M020
Vacation Shimmer OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc150cbb23-fcb9-ed6f-e063-6394a90a597c2024-05-16WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.d66dfcec-ad40-3a0b-e053-2995a90aa0062024-05-14WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Fluid Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.d66c88a1-7684-1043-e053-2a95a90aa2aa2024-05-14WarningsExact identifier
application number: M020
Jack BlackTITANIUM DIOXIDE, ZINC OXIDEJack Black L.L.C181d5bf3-ce91-cb2c-e063-6294a90a51c42024-05-10WarningsExact identifier
application number: M020
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs181e3f34-c5b2-0976-e063-6394a90a9a782024-05-10WarningsExact identifier
application number: M020
SABIYA Broad Spectrum SPF-30ZINC OXIDESABIYA, LLCbc403672-7576-49a6-9a29-4f6cb19af7a42024-05-09WarningsExact identifier
application number: M020
SABIYA Broad Spectrum SPF-50ZINC OXIDESABIYA, LLC4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c2024-05-09WarningsExact identifier
application number: M020
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs180b2939-5ae4-88fb-e063-6394a90aad932024-05-09WarningsExact identifier
application number: M020
UV Daily Deep TintOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.c12fa9a4-d7e5-46bf-9bfb-1cbbaa73b4502024-05-09WarningsExact identifier
application number: M020
Chemical Sunscreen SPF50OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREENSwiss-American CDMO, LLC50f47495-93aa-4e11-a153-d4c847a36c992024-05-08WarningsExact identifier
application number: M020
UV Clear Deep TintOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.ead07d51-9400-4f0a-8966-7052dfae67bc2024-05-08WarningsExact identifier
application number: M020
Essence Pout Protector SPF 20 Lip BalmHOMOSALATE, OCTISALATE, ZINC OXIDEcosnova GmbH17e483c5-6e47-9a50-e063-6394a90aa6042024-05-07Warnings, Adverse reactionsExact identifier
application number: M020
MIRABELLA Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTISALATE, AVOBENZONEGDM ENTERPRISES LLC3ac847d5-a75d-4b32-84e1-70e4282c0d722024-05-06WarningsExact identifier
application number: M020
MELAN SPF-30 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATEMELAN INC.75fcef12-bc33-44a7-acda-77d5d7bca2bc2024-05-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87357-001-018735700010130 mL in 1 BOTTLE, GLASS (87357-001-01) 30 ml2026-01-22NoNoCurrent