FDA.reportPublic FDA data

it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All Shades

Product NDC
82046-334
11-digit product format
820460334
Labeler code
82046
Product ID
82046-334_8135f25c-a643-4fd3-a6d5-dcd42f769645
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
90; 63 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All Shades
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE90 mg/mL
ZINC OXIDE63 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86eea4df-4191-4e05-9f05-4a98ef8c2a4dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82046-334-01it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All Shades1 in 1 CARTONLOTION11
82046-334-01it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All Shades30 mL in 1 TUBELOTION301
82046-334-02it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All Shades1 in 1 CARTONLOTION11
82046-334-02it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All Shades75 mL in 1 TUBELOTION751

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 154 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC44fe7468-001c-f2ee-e063-6394a90ae3b42025-12-02WarningsExact identifier
application number: M020
ATTITUDE Super Leaves Lip Balm SPF15 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ff1fc0-9ac5-2c9a-e063-6294a90a46322025-12-02WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 CoconutZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ff5675-fd8d-b665-e063-6294a90a1e0b2025-12-02WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 PineappleZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ffb35b-80f4-7ddb-e063-6394a90a2cbb2025-12-02WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44ffd469-0205-846f-e063-6294a90af6b52025-12-02WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.daf0291e-770c-eaf2-e053-2a95a90a0b672025-12-01WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Dewy SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE7054144e0098c-170f-ca51-e063-6294a90aed202025-12-01WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Sun EssenceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e194cd-ea61-71b3-e063-6394a90ac4862025-12-01WarningsExact identifier
application number: M020
Venture Performance Sun Protection Mineral Sunscreen SPF 50ZINC OXIDEVenture Performance Inc630fc5c2-a315-4e26-9bd9-5f8533d759082025-12-01WarningsExact identifier
application number: M020
EMINENCE Red Currant Protective MoisturizerOCTINOXATE, ZINC OXIDEEminence Organic Skin Care7eca62af-6f70-44ec-879e-74712163c4e02025-12-01WarningsExact identifier
application number: M020
CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless PrimerAVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENECharlotte Tilbury Beauty Ltd.2b215ecb-7c3a-63db-e063-6394a90aa88f2025-12-01WarningsExact identifier
application number: M020
P.CALM Water Barrier Sunscreen SPF 50 Broad SpectrumHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONELIFE WITHCORPORATION Inc.44ea9fb4-8e01-6969-e063-6294a90a6a942025-12-01WarningsExact identifier
application number: M020
ROC MULTI CORREXION - EVEN TONE AND LIFT - 5-In-1 Chest, Neck, and Face Cream Sunscreen - Broad Spectrum SPF 30AVOBENZONE, HOMOSALATA, OCTISALATE, OCTOCRYLENERoc Skincare2b3656d6-4b3a-9ef2-e063-6294a90acaa62025-12-01WarningsExact identifier
application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONERare Beauty Brands Inc.44ec0db5-4437-e4a3-e063-6294a90a9a002025-12-01WarningsExact identifier
application number: M020
RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare2888a198-116b-8441-e063-6394a90a0f952025-12-01WarningsExact identifier
application number: M020
ReefSafe Very High Sun Protection sunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ec619f-ed3b-2fd3-e063-6294a90a858b2025-12-01WarningsExact identifier
application number: M020
Reef safe - Face and Body sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38603298-e8da-e4c7-e063-6394a90aca3b2025-12-01WarningsExact identifier
application number: M020
ReefSafe Baby and Toddlers Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44dd513e-ebaa-0d6a-e063-6394a90a78b72025-11-30WarningsExact identifier
application number: M020
Safe4Kidz Natural Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ddc0ae-a977-3adf-e063-6294a90a08982025-11-30WarningsExact identifier
application number: M020
Safe4Kidz Baby Zinc Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ddc4d8-3f3b-5d11-e063-6294a90ae88a2025-11-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82046-334-01820460334011 TUBE in 1 CARTON (82046-334-01) / 30 mL in 1 TUBE1 tube2025-11-15NoNoCurrent
82046-334-02820460334021 TUBE in 1 CARTON (82046-334-02) / 75 mL in 1 TUBE1 tube2025-11-15NoNoCurrent