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 129 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Age Defying SunscreenZINC OXIDEGINAMARIE Products35837cf7-91e5-f9ec-e063-6394a90aa91e2025-12-12Exact identifier
application number: M020
Mineral Sunscreen Face plus BodyZINC OXIDEKS Esthetics, LLC390a4d8d-b47f-0d9a-e063-6394a90a9b532025-12-12Exact identifier
application number: M020
Mineral Sunscreen Tinted Zinc OxideZINC OXIDEKS Esthetics, LLC3909e657-97a5-dd3c-e063-6394a90a10eb2025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS36608832-22d8-bc76-e063-6394a90abac62025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660af9e-d60f-c33e-e063-6394a90a3a052025-12-12Exact identifier
application number: M020
Hydrating Antioxidant Sunscreen tintedZINC OXIDEKRISTI REDD ESTHETICS366149e2-b03c-e798-e063-6394a90a6a1d2025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660e701-1373-eef4-e063-6394a90a61402025-12-12Exact identifier
application number: M020
Hydrating Antioxidant Sunscreen tintedZINC OXIDEKRISTI REDD ESTHETICS3661251d-b907-8df6-e063-6294a90a1c732025-12-12Exact identifier
application number: M020
sheer tinted sunscreenTITANIUM DIOXIDE, ZINC OXIDESARA ELIZABETH SKINCARE3b177c49-ed8c-42b9-e063-6294a90a82c62025-12-12WarningsExact identifier
application number: M020
Canopy UntintedZINC OXIDEBORREGO SPRINGS SKINCARE LLC35824cd5-0036-7886-e063-6394a90ae6782025-12-12Exact identifier
application number: M020
Canopy SPF 40 TintedZINC OXIDEBORREGO SPRINGS SKINCARE LLC358319c5-ae35-cb3b-e063-6394a90ad77f2025-12-12Exact identifier
application number: M020
Non-Tinted Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581ab49-ef55-3743-e063-6394a90a3bd52025-12-12Exact identifier
application number: M020
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581cf33-3520-42f7-e063-6394a90a6f932025-12-12Exact identifier
application number: M020
Mineral Sunscreen For Face and BodyZINC OXIDESkin Philosophy by Kelly358248e6-16cf-6f9b-e063-6394a90a55d72025-12-12Exact identifier
application number: M020
Replenishing Mineral SunscreenZINC OXIDESkin Philosophy by Kelly35828e76-66db-49de-e063-6294a90a2b992025-12-12Exact identifier
application number: M020
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3592b2c7-295a-7c60-e063-6394a90a387b2025-12-12Exact identifier
application number: M020
Mineral Sunscreen For Face and BodyZINC OXIDESkin Philosophy by Kelly3592fd5f-13d1-9aec-e063-6394a90abd672025-12-12Exact identifier
application number: M020
Replenishing Mineral SunscreenZINC OXIDESkin Philosophy by Kelly359371f2-2407-e1a1-e063-6294a90a21652025-12-12Exact identifier
application number: M020
Non Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC397fc3c9-9d30-adcf-e063-6394a90ac7612025-12-12Exact identifier
application number: M020
Non Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC39800bf1-e01a-e1c8-e063-6294a90a53bf2025-12-12Exact 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