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 161 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soft Bisque Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Ince8b11940-6ac4-4c80-a732-2f86f2b7ebfe2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Alabaster Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incd54a35a2-4f5d-4aec-8be4-1d8e00d4618f2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Alabaster Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incd6be5b8e-0094-40de-91a6-bc52b3f8a9872025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Creamy Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incda149594-8a75-4b8d-9b6a-068231ce153b2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Pure Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc95821b1c-c894-4b3f-94c2-0083497302032025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Porcelain Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inccce60274-ef8a-4638-a2c8-e869fc9e2a7c2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Quiet Rose Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc776f5cb5-9d0e-4057-9600-e18b2b8a249a2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Sandy Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc2406806e-f5ff-4c54-bf33-a96afaea1ccc2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Sesame Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc70b94df9-2160-450c-a722-cb842f58c3192025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Simply Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc7797fcb4-2080-415a-9b4b-5410518380932025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Soft Bisque Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Ince5a63ffc-32e6-4bb1-907a-8697791f57bf2025-11-19WarningsExact identifier
application number: M020
Vanilla Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc98ebaa5c-ba28-4e70-a45c-6545eb756d8f2025-11-19WarningsExact identifier
application number: M020
Softlips VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8dff782f-7201-4ad9-94d2-672058f817b82025-11-19WarningsExact identifier
application number: M020
Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum SPF30AVOBENZONE, OXTINOXATE, OCTOCRYLENE, OXYBENZONEBaxter Laboratories Pty. Ltd.43923c68-87ad-1ab7-e063-6394a90adf7a2025-11-18WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e36351-4caf-3393-e063-6394a90a00b12025-11-18WarningsExact identifier
application number: M020
Perfecting Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e454cf-dac8-4c2f-e063-6394a90a70972025-11-18WarningsExact identifier
application number: M020
Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEH.E.B.43e55eb7-6572-bd88-e063-6294a90aa7ee2025-11-18WarningsExact identifier
application number: M020
Bare Expert Finish Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incff396aca-cf64-45f8-ba2e-c4fc55d6484b2025-11-18WarningsExact identifier
application number: M020
ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMerle Norman Cosmetics, Inc.d10272ea-aedd-5759-e053-2a95a90a3ab32025-11-18WarningsExact identifier
application number: M020
DAYDREAM Broad Spectrum Sunscreen SPF 40ZINC OXIDEDrmtlgy, LLCbd0981cb-49ce-4eaf-bd9e-db48f56b73142025-11-18WarningsExact 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