FDA.reportPublic FDA data

HERA BLACK CUSHION FOUNDATION 21W1

Product NDC
43419-246
11-digit product format
434190246
Labeler code
43419
Product ID
43419-246_5bc7464c-f00d-f33d-e063-6294a90a408d
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Amorepacific Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-01
Substance
OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
.9743; .249; .294 g/15g; g/15g; g/15g
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
HERA BLACK CUSHION FOUNDATION 21W1
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE.9743 g/15g
TITANIUM DIOXIDE.249 g/15g
ZINC OXIDE.294 g/15g

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 134 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultimate Physical SunscreenZINC OXIDEHALEM DERMATOLOGY PLLC35bc5ff5-8eb8-54cf-e063-6394a90ae3c22025-12-11Exact identifier
application number: M020
Tinted Mineral Daily SunscreenTITANIUM DIOXIDE ,ZINC OXIDEJordan Macall Acne & Anti-Aging Skincare LLC350ad191-e51c-083d-e063-6394a90aa6462025-12-11Exact identifier
application number: M020
Ultimate Physical SunscreenZINC OXIDEHALEM DERMATOLOGY PLLC35be5dc0-861f-3738-e063-6394a90a23ca2025-12-11Exact identifier
application number: M020
Tinted Mineral Daily SunscreenTITANIUM DIOXIDE ,ZINC OXIDEJordan Macall Acne & Anti-Aging Skincare LLC350b2246-6e00-38fc-e063-6294a90ae3822025-12-11Exact identifier
application number: M020
Calming Protection SPF40ZINC OXIDEFRESH FACED SKIN CARE LLC35d0c081-67b4-ce46-e063-6294a90ad8222025-12-11Exact identifier
application number: M020
Tinted Facial Protection SPF40TITANIUM DIOXIDE, ZINC OXIDEFRESH FACED SKIN CARE LLC35d08e2a-b118-8634-e063-6294a90a918d2025-12-11Exact identifier
application number: M020
Total Body Block SunscreenZINC OXIDETHE COMPLEXIONIST38f53f6a-8e68-e30f-e063-6394a90afef22025-12-11Exact identifier
application number: M020
Fair Skin Anti-AgingZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351bb329-90ea-f19a-e063-6394a90af1072025-12-11Exact identifier
application number: M020
Oil Free Anti-AgingZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351b4870-d9bd-c356-e063-6394a90a77632025-12-11Exact identifier
application number: M020
Anti-Aging Sun Protection NTTITANIUM DIOXIDE, ZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351a20df-bd8a-8ea6-e063-6294a90abaaf2025-12-11Exact identifier
application number: M020
Tinted Primer Anti-AgingTITANIUM DIOXIDE, ZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351aaaad-44ce-3558-e063-6294a90a2b462025-12-11Exact identifier
application number: M020
Total Body Block SunscreenZINC OXIDEADR SUNCARE38f4928c-6389-5aa1-e063-6294a90a8f9d2025-12-11Exact identifier
application number: M020
Magic VeilZINC OXIDETHE COMPLEXIONIST38f574ad-c4bf-fca1-e063-6394a90a00c52025-12-11Exact identifier
application number: M020
Magic VeilZINC OXIDETHE COMPLEXIONIST38f5a0b9-bbe2-50f4-e063-6294a90a10d72025-12-11Exact identifier
application number: M020
Daily Tinted Antioxidant Mineral SunscreenZINC OXIDEMONIKA G KIRIPOLSKY MD INC.3b3f19c1-4bff-315f-e063-6394a90a9a852025-12-11WarningsExact identifier
application number: M020
Daily Repair Moisturizing TintedZINC OXIDESkintique37dd83db-aa43-7f66-e063-6294a90a893b2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing Non TintedZINC OXIDESkintique37de01d0-7694-69c1-e063-6394a90acf0a2025-12-11Exact identifier
application number: M020
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37dd5228-5fe4-5e7b-e063-6294a90adffb2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing Non TintedZINC OXIDESkintique37ddc177-376d-b2fe-e063-6294a90a5e072025-12-11Exact identifier
application number: M020
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37de2f44-e0da-0d1c-e063-6294a90ae18b2025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43419-246-31434190246311 CONTAINER in 1 CARTON (43419-246-31) / 15 g in 1 CONTAINER1 container2026-09-01NoNoCurrent