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_5f02d736-8d48-0501-e063-6394a90a30ba
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 342 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium ShadeSPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADEAutumn Harpfd6807e1-c8c0-b361-e053-6294a90aea0c2023-06-05WarningsExact identifier
application number: M020
Thinksport Clear Zinc SPF 50ZINC OXIDEthinkOperations,LLCb5ce523f-eee8-f1a8-da19-b3dc14f8a58e2023-05-31WarningsExact identifier
application number: M020
Thinksport Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC77b63c0b-353b-4f5f-95c7-6f7eeab814712023-05-30WarningsExact identifier
application number: M020
Think Kids Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC25c59820-a08d-4abe-87ae-a787ac8b2ac22023-05-30WarningsExact identifier
application number: M020
Topix Mineral Mattifying Tinted Sunscreeninted SPF 50ZINC OXIDETopiderm, Inc.46c6f20f-4bb6-47c6-9eac-17ca97bb14a72023-03-20WarningsExact identifier
application number: M020
Replenix Sunscreen SPF 50ZINC OXIDETopiderm, Inc.9223ffa8-7af3-4407-9170-482afec536d82023-02-24WarningsExact identifier
application number: M020
Bath and Body Works SPF20 Coconut Lip BalmSPF20 LIP BALMAutumn Harpf5744a48-2b39-4949-e053-2a95a90ab15d2023-02-24WarningsExact identifier
application number: M020
Replenix Tinted Sunscreen SPF 50ZINC OXIDE AND OCTINOXATETopiderm, Inc.1fda4a54-e323-4f3c-b659-bded4b1b3dd02023-02-22WarningsExact identifier
application number: M020
Topix Mineral Mattifying Tinted Sunscreen SPF 50ZINC OXIDETopiderm, Inc.ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e912023-02-22WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
application number: M020
Essential Moisturizing SunscreenZINC OXIDE, OCTINOXATETopiderm, Inc.450d916e-4c77-489e-86b1-78b6863554762023-02-09WarningsExact identifier
application number: M020
Mineral Repair SPF 45ZINC OXIDETopiderm, Inc.84580f10-3119-4253-87a6-53d24a1f22272023-02-07WarningsExact identifier
application number: M020
Think Aloe and Tea Leaves Zinc oxideZINC OXIDEthinkOperations,LLC9965ccd1-821d-4d9d-8a56-e87440b809ee2023-02-02WarningsExact identifier
application number: M020
Replenix Lip Therapy homosalateHOMOSALATETopiderm, Inc.b60dc004-d713-47bc-a6e9-ea4783aa70192023-02-02WarningsExact identifier
application number: M020
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
application number: M020
Tinted Lip Balm SPF30 Wild PeonySPF30 LIP BALMAutumn Harpd0604720-623a-e8a9-e053-2995a90ab0e62023-01-10WarningsExact identifier
application number: M020
Basin French Pear SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a39d91c-2dcf-71d6-e063-6394a90a54742022-02-10WarningsExact identifier
application number: M020
Basin Mexican Vanilla SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3a63d3-c7e0-bf03-e063-6394a90a16622022-02-10WarningsExact identifier
application number: M020
Basin Norwegian Berry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3c0aa0-7501-7ef0-e063-6294a90a9f942022-02-10WarningsExact identifier
application number: M020
Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35OCTINOXATE AND OXYBENZONEGroupe Marcelle Inc.c24ac3ad-b2e2-4381-bd80-a499da0e06702021-12-14WarningsExact 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