FDA.reportPublic FDA data

OMIC MINERAL SUNSCREEN

Product NDC
79009-902
11-digit product format
790090902
Labeler code
79009
Product ID
79009-902_5d43e4bd-24e5-7c16-e063-6294a90afbf8
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Mitchell Cosmetics, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-02
Substance
ZINC OXIDE
Active strength
.18 g/g
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
OMIC MINERAL SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE.18 g/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79009-902-80OMIC MINERAL SUNSCREEN1 g in 1 BOTTLE, DISPENSINGLOTION11

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 244 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDEfmg Co.Ltdf114e45c-6c31-2382-e053-2995a90ac7542025-01-01WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDEfmg Co.Ltdd3078dd2-ae9c-d81a-e053-2a95a90a47bf2025-01-01WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDEfmg Co.Ltdd3078dd2-ae9e-d81a-e053-2a95a90a47bf2025-01-01WarningsExact identifier
application number: M020
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdf8377d02-6c58-c240-e053-6294a90a44c02025-01-01WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltdd67faeb3-0b73-5b6e-e053-2a95a90aac2b2025-01-01WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd02e63ed6-1f49-45c0-e063-6394a90a58bf2025-01-01WarningsExact identifier
application number: M020
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd2fadd51-6bd8-ae70-e053-2995a90a62132025-01-01WarningsExact identifier
application number: M020
Jergens Natural Glow Face Moisturizer Medium to Deep Skin TonesAVOBENZONE,OCTISALATE, OCTOCRYLENEKao USA Inc.ff601f5c-b8ed-ee21-e053-6294a90aadba2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d309eebc-44f4-bce6-e053-2995a90a3bd22025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d30a3bcb-5113-0a85-e053-2995a90a39372025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.d30a9f96-f99b-4610-e053-2995a90a3f912025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot BeigeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d30a7ecc-ea54-d1b9-e053-2995a90a70172025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Natural BeigeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d30a87b9-90f9-35b2-e053-2995a90aea2c2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.d30ab7a5-d38c-ba62-e053-2995a90a57fd2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6e82b4e-ce83-0ca2-e053-2a95a90a88de2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDELG H&H Co., Ltd.0166d193-fc4d-51f7-e063-6294a90aaf322025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6e831a1-c82f-3e1f-e053-2a95a90ae1f62025-01-01WarningsExact identifier
application number: M020
ISA KNOX LXNEW PLATINUM SCULPTING DAY BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6e82b4e-ce84-0ca2-e053-2a95a90a88de2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.016798a8-4275-47d0-e063-6294a90a5aca2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDELG H&H Co., Ltd.f1166cb4-b471-7043-e053-2a95a90a7fa72025-01-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79009-902-80790090902801 g in 1 BOTTLE, DISPENSING (79009-902-80) 1 g2026-03-02NoNoCurrent