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_5cb88b91-b0be-58aa-e063-6294a90acb79
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 255 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SANDOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b3236-3f3d-c9e8-e063-6394a90a74432024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNYOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b416d-ce02-3462-e063-6294a90a38f02024-12-19WarningsExact identifier
application number: M020
PuttisuTITANIUM DIOXIDE, ZINC OXIDEJellycup, Inc.a032331a-6724-d2cd-e053-2995a90ac15a2024-12-19WarningsExact identifier
application number: M020
Dr. C. Tuna Resurface Essential Day Cream SPF 30HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONEFarmasi US LLCde493e30-d135-9def-e053-2995a90ae49a2024-12-19WarningsExact identifier
application number: M020
toty Ilumina CC Cream 1NTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe4efe14e-7d46-78c0-e053-2995a90a23642024-12-19WarningsExact identifier
application number: M020
Aruba Sun SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd8b28ce6-e938-c6e3-e053-2a95a90acc292024-12-19WarningsExact identifier
application number: M020
DCH Pain Relief Roll-OnLIDOCAINE HCL 4%Derma Care Research Labs, LLCfda35d37-f36e-efc8-e053-6294a90a2bb82024-12-19WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50 KidsAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd53ff8f5-0b06-1e8b-e053-2a95a90ab9242024-12-19WarningsExact identifier
application number: M020
Fresh Coast SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLC043cadde-ba07-7c77-e063-6394a90abee62024-12-19WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Derma Care Research Labs, LLCd438be95-0f88-69d7-e053-2995a90a982e2024-12-19WarningsExact identifier
application number: M020
Pavin SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCe945f9df-0aed-469c-e053-2995a90ab6aa2024-12-19WarningsExact identifier
application number: M020
Bee Bald Smooth Plus Daily Moisturizer SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 6%Derma Care Research Labs, LLC051b68f9-5d6b-3cd7-e063-6394a90aeb352024-12-19WarningsExact identifier
application number: M020
MKMen Advanced Facial Hydrator Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.484e92db-09a2-4e93-aa7e-d91dbda315552024-12-19WarningsExact identifier
application number: M020
SPF 50 Sunscreen UnfragrancedAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLC05e4706b-1955-aba8-e063-6294a90a29c72024-12-19WarningsExact identifier
application number: M020
Rubber Ducky SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCcf32b3a0-de88-b866-e053-2a95a90a3f322024-12-19WarningsExact identifier
application number: M020
SPF 50 Sunscreen Rocky MountainAVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Derma Care Research Labs, LLCa216d48f-4ed4-6008-e053-2a95a90a8c9a2024-12-19WarningsExact identifier
application number: M020
Rod and Rifle SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Derma Care Research Labs, LLCfc61847b-cb61-97b1-e053-6394a90ae1b92024-12-19WarningsExact identifier
application number: M020
Habana Brisa SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%Derma Care Research Labs, LLCdb0d6dec-d0ee-6160-e053-2a95a90a2c6e2024-12-19WarningsExact identifier
application number: M020
Caribbean Breeze SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Derma Care Research Labs, LLCf8730f9c-43c1-f4d3-e053-6294a90a18092024-12-19WarningsExact identifier
application number: M020
Caribbean Breeze SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCf8735925-dcb2-6723-e053-6294a90a51f42024-12-19WarningsExact 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