FDA.reportPublic FDA data

SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25

Product NDC
82953-080
11-digit product format
829530080
Labeler code
82953
Product ID
82953-080_59d74e35-4758-9262-e063-6394a90aa3bc
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-25
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
2.7; 16.2 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
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25
Brand name suffix
01
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE2.7 g/100mL
TITANIUM DIOXIDE16.2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
59d74e3f-e3fa-a7a9-e063-6294a90a76e5Available 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 297 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANYZINC OXIDERms organics LLC1a1aebea-ed0c-ac92-e063-6294a90aeae62024-06-04WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc OnlyZINC OXIDESPF Ventures, LLC1a1bf910-f1bc-bd75-e063-6294a90a663f2024-06-04WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
application number: M020
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.19b19023-1340-6609-e063-6394a90a6eaf2024-05-30WarningsExact identifier
application number: M020
EltaMD UV Sport SPF50ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREENCP Skin Health Group, Inc.dffc3fde-5b6e-4a62-8289-9733be43455b2024-05-30WarningsExact identifier
application number: M020
Vacation by Vacation Scent and Shimmer DuoAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.aef8388f-84bb-4e2b-8ae2-aa64f415a6322024-05-28WarningsExact identifier
application number: M020
SPF50 Sunscreen CariposaZINC OXIDETalent Brands Company LLC1938fa13-875a-140e-e063-6294a90a55142024-05-24WarningsExact identifier
application number: M020
Derma E Vitamin C Weightless Moisturizer SPF 45ZINC OXIDEderma ea3b404a6-e4b1-4c08-a8ef-77446dd2e4112024-05-24WarningsExact identifier
application number: M020
COOLA Classic Liplux Lip Balm SPF 30 OriginalAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCeeb420f0-c92f-0d96-e053-2a95a90afe362024-05-22WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Nude BeachTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee2842c3-65e0-3904-e053-2a95a90aabff2024-05-22WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 FirecrackerTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee026a1c-885b-256f-e053-2a95a90af5642024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 50 Mineral Sunscreen Vanilla CocoTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCec96dee8-85e8-3147-e053-2995a90aaf532024-05-22WarningsExact identifier
application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze GoddessTITANIUM DIOXIDECOOLA, LLCeeb406c6-a543-379a-e053-2995a90a49982024-05-22WarningsExact identifier
application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh RoseTITANIUM DIOXIDECOOLA, LLCee01642f-478e-b307-e053-2a95a90a7d812024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 30 Mineral Sunscreen Coco MangoZINC OXIDECOOLA, LLCeca9ae89-19dc-516d-e053-2995a90a46982024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Matte Untinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCecabcc89-fb09-41a9-e053-2995a90a8b312024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Matte Tinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee018c21-dca7-28aa-e053-2a95a90a3bdb2024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 30 Mineral Sunscreen Citrus CoolerZINC OXIDECOOLA, LLCecaad342-1873-60bc-e053-2995a90a59522024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Shimmer SPF 30 Golden DazeTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeeb70034-0f8d-a46d-e053-2a95a90a81302024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Shimmer SPF 30 Diamond DustTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeec83ecb-d0ab-7857-e053-2995a90a40ed2024-05-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-080-018295300800130 mL in 1 TUBE (82953-080-01) 30 ml2026-08-25NoNoCurrent