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 315 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited4d11cc46-3942-1561-e054-00144ff8d46c2023-12-12WarningsExact identifier
application number: M020
ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEXZINC OXIDESIBORG LLC9c4897f8-8fcb-4a0f-b42e-f582e2934f022023-12-12WarningsExact identifier
application number: M020
Byoma Moisturizing Gel Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEENGLEWOOD LAB, INC.f63fe60f-9863-1dfb-e053-2a95a90a90a52023-12-12WarningsExact identifier
application number: M020
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 MinTITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.5742da4b-6713-4de9-8ab8-b2bf2983371a2023-12-12WarningsExact identifier
application number: M020
restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea ComplexZINC OXIDERESTORSEA INC80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a2023-12-12WarningsExact identifier
application number: M020
ReVive Fermitif Neck Renewal SPF 15AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONEGurwitch Products, LLCde54d4ff-f9b4-4a12-95ea-fc2b61bee1c32023-12-12Exact identifier
application number: M020
Laura Mercier Flawless Skin Daily Face Shield SPF 40OCTINOXATE, TITANIUM DIOXIDEGurwitch Products, LLCf86729cd-682f-47b2-9bfa-1113721bfec02023-12-12WarningsExact identifier
application number: M020
Boscia BB SPF 27 PATITANIUM DIOXIDEBoscia LLC5dc86c0b-c340-4643-a174-a6b4c0826ca92023-12-12WarningsExact identifier
application number: M020
Dr.Denese SPF 30 Defense DayZINC OXIDE, OCTINOXATESkinScience Labs, Inc511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa2023-12-12WarningsExact identifier
application number: M020
Boscia Daily Hydration SPF 15 Broad Spectrum For Normal To Oily SkinAVOBENZONE, OCTINOXATEBoscia LLC0c987cb9-7049-44b9-9935-647b0411a7342023-12-12WarningsExact identifier
application number: M020
Boscia BB Broad Spectrum SPF 27 PA Self Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC82a23aab-404f-46bb-afaa-8ba9b9bdbefd2023-12-12WarningsExact identifier
application number: M020
Boscia Restorative Day Moisture Broad Spectrum SPF 15 For Dry SkinAVOBENZONE, OCTINOXATEBoscia LLC657b04c6-d15b-470b-92e6-e59ed7e8b1162023-12-12WarningsExact identifier
application number: M020
Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50 PlusHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENEMarket Americac1898e00-05f1-4e28-9fa8-8cda1b1785952023-12-12WarningsExact identifier
application number: M020
Boscia BB BRONZE Broad Spectrum SPF 27 PA Self-Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC5f5fb9f5-00be-420a-b19a-b753c45f9a882023-12-12WarningsExact identifier
application number: M020
Boscia Self-Defense Vital Antioxidant Moisture Broad Spectrum SPF 30AVOBENZONE, OCTINOXATEBoscia LLC7d948951-598a-4a38-94a2-d357ee7f4d1e2023-12-12WarningsExact identifier
application number: M020
Restorative Day Moisture SPF 15OCTINOXATE, AVOBENZONEBoscia LLC01f17133-7f29-4f8e-a52c-c4466e4abefc2023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 03TITANIUM DIOXIDE3LAB, Inc.8a42a9d8-b9c6-45fb-8264-15f36e2765f02023-12-12WarningsExact identifier
application number: M020
3LAB Hydra Day SPF 20 Broad Spectrum Water-Based SunscreenOCTINOXATE, OCTISALATE, AVOBENZONE3LAB, Incd539b851-c4b2-40a2-9562-e3a95a86b7442023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT Lite Sunscreen SPF 30 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDE3LAB, Inc3052af3f-8923-47bc-be6e-17396275363a2023-12-12WarningsExact identifier
application number: M020
Isa SunGuard SPF 30ZINC OXIDE, TITANIUM DIOXIDEIsagenix International, LLCabe1e345-6ea2-43b3-8613-b5b5e04c87b72023-12-12WarningsExact 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