FDA.reportPublic FDA data

BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN

Product NDC
85053-007
Requested package NDC
85053-007-01
11-digit product format
850530007
Labeler code
85053
Product ID
85053-007_54fc80b7-8f6d-e2be-e063-6394a90a4b59
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Shantou Woodsleep Biotechnology Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-24
Substance
PHENYLBENZIMIDAZOLE SULFONIC ACID; AVOBENZONE; TITANIUM DIOXIDE; OCTOCRYLENE
Active strength
1; .75; 4.5; 1 mg/50mg; mg/50mg; mg/50mg; mg/50mg
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
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLBENZIMIDAZOLE SULFONIC ACID1 mg/50mg
AVOBENZONE.75 mg/50mg
TITANIUM DIOXIDE4.5 mg/50mg
OCTOCRYLENE1 mg/50mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9YQ9DI1W42Internal UNII lookup
G63QQF2NOXInternal UNII lookup
15FIX9V2JPInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
54fc80b7-8f6c-e2be-e063-6394a90a4b59Available on FDA.report

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 1 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm DuskSPF50Grace And Fire USA Inc.2735ab0f-5eec-04c5-e063-6394a90aa60e2026-10-01WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm BejewelledSPF50Grace And Fire USA Inc.274a0544-6c71-4d91-e063-6394a90a22472026-10-01WarningsExact identifier
application number: M020
TRILIPIDERM All-Body Moisture Retention SPF-30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENETrilipid Research Institute, LLC7f34de0a-eeb3-4b71-9abd-53d03266d9932026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC6a43173f-41f9-4207-a0db-53bc8db6f4a42026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCd69b4992-d7e6-4bd7-b144-0485e35818a62026-09-10WarningsExact identifier
application number: M020
Hydra Finish SPF 15HOMOSALATE, OCTINOXATEGuinot4047e8ec-834a-41e6-a144-5649a7718de42026-09-10WarningsExact identifier
application number: M020
HYDRA BEAUTE SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot806d1e18-a3fc-43df-a52a-a640902d08872026-09-10WarningsExact identifier
application number: M020
Pur Confort SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot2fe0656f-f924-48da-91bf-d6f3d98e8fd92026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC51f3d6ca-3189-4380-9afb-4259ba8782742026-09-10WarningsExact identifier
application number: M020
Sun Logic Creme Solaire Visage et corps SPF 30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinotb0a95379-998a-4cda-bae7-63faf3d6f3c82026-09-10WarningsExact identifier
application number: M020
Sun Logic Lait Solaire Corps SPF 20AVOBENZONE, HOMOSALATE, OCTOCRYLENEGuinotd9d2cee0-9189-42d0-b1ab-78b97141b1282026-09-10WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 301226 W AESTHETICS5b0ef395-a7dd-378e-e063-6394a90a5dce2026-09-09WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
application number: M020
Baloom 2% Panthenol Hydro Airy SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENEARSN KOREA5148b638-f8a4-fa8b-e063-6294a90ac2082026-09-08WarningsExact identifier
application number: M020
Double-Duty Face MoisturizerMOSITURIZING SUNSCREENJack Black, LLC672be406-e3a1-47b4-8ef6-ee2b62baae962026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85053-007-018505300070150 mg in 1 BOX (85053-007-01) 50 mg2026-06-24NoNoCurrent