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 188 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunglaze Body Gel Cream Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC3e6658a1-ae6a-9d19-e063-6294a90acae72025-09-09WarningsExact identifier
application number: M020
CLARINS Extra Firming Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarins57f07e8a-1043-47e4-9d7b-6e78fdc341192025-09-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC1d3218e6-8687-4a94-8bf7-3a867920cd1c2025-09-08WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC6c578ef8-5648-4428-b9a2-0952f96252532025-09-08WarningsExact identifier
application number: M020
Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Sheer Shimmer 10AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC16ac7877-8dfd-3d69-e063-6394a90a5a8a2025-09-08WarningsExact identifier
application number: M020
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD388fb3db-29d2-bb29-e063-6394a90a4efb2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 15N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L8d76a963-bdf5-44a1-b1d6-27d1a3aaa1ae2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 16N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.Ld279693f-2254-4f3c-a121-144f95f9f25d2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 12N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L7f007540-8271-4d85-9d1e-b2b273ca05f82025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 17W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L5198d3df-ffa8-45eb-93d1-11e9f3961b922025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 18N MediumZINC OXIDEDolce & Gabbana Beauty S.R.La82d85c4-c6ef-4083-b67a-2d6b0e8fc10d2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 19W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L4ee6cac6-f649-436c-ada2-e024b86add692025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 24N MediumZINC OXIDEDolce & Gabbana Beauty S.R.Ledd4e8c3-b47a-4cfe-bf20-e856edb76e212025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 21W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L457f0a5c-c543-44f8-82d6-1096a8aab9842025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 22N MediumZINC OXIDEDolce & Gabbana Beauty S.R.L1452ffc4-a83f-472f-ae70-9e1002f889452025-09-08WarningsExact identifier
application number: M020
Protect and Hydrate Radiance Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.3e4db4f8-cba5-dbfd-e063-6394a90ab0a02025-09-08WarningsExact identifier
application number: M020
Ocean Potion Suncare 50 Continuous Sunscreen Scent of SunshineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3e518d8a-f52b-4ae1-e063-6394a90aaa1e2025-09-08WarningsExact identifier
application number: M020
Ocean Potion Suncare 50 Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3c5a624a-8844-b782-e063-6294a90a478c2025-09-08WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dbb07e2-971c-284d-e063-6294a90a437f2025-09-06WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3e069cb2-c4c5-abf5-e063-6394a90a56b02025-09-06WarningsExact 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