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 239 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPURA VIDA BODY & MIND SPA, INC.04b38e97-c4b3-df23-e063-6394a90ae6b72025-01-08WarningsExact identifier
application number: M020
EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPremier Plastic Surgerybc9221fe-89b4-4ad8-e053-2995a90aa0412025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEEmerald Aesthetics LLCf80f439d-f4f0-fbf3-e053-6294a90ae0ef2025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESuzanne's Skin2soul LLCfea667a1-6bec-9819-e053-6394a90a9b962025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBEAUTY SENSE MEDSPA INCfe93a337-8d2f-35d3-e053-6294a90acb3c2025-01-08WarningsExact identifier
application number: M020
Sunscreen Emulsion SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co.1d560670-026b-bd34-e063-6394a90a9af42025-01-08WarningsExact identifier
application number: M020
Allies of Skin Sunless Tan SPF 50 Daily Self TannerAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEALLIES GROUP PTE. LTD.4d58de8e-875b-4b77-b0ef-b9d760aaced82025-01-07WarningsExact identifier
application number: M020
Pop Zinc SunscreenZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd2b29ddb2-5730-8a67-e063-6394a90ae4162025-01-07WarningsExact identifier
application number: M020
COOLA Anti-Aging Sun Silk Drops Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUMCOOLA LLCbbb29d0c-ae1f-409e-8fd6-ff3ea34dc9c22025-01-07WarningsExact identifier
application number: M020
Advanced Day Ultimate Protect Sunscreen SPF 50BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATEMedik8 Limited29071920-ba90-871a-e063-6294a90aee272025-01-06WarningsExact identifier
application number: M020
Dimples Bath Co - Sunstick New Kid On The BlockZINC OXIDEDimples Bath Co. LLC26f682f4-2440-f111-e063-6294a90ab4b72025-01-06WarningsExact identifier
application number: M020
Diaper Rash Cream Happy CheeksDIAPER RASH HAPPY CHEEKSDimples Bath Co. LLC26cef2eb-a133-11ec-e063-6394a90a0f082025-01-06WarningsExact identifier
application number: M020
New Kid on the BlockZINC OXIDEDimples Bath Co. LLC26fec959-c234-6692-e063-6394a90a66002025-01-06WarningsExact identifier
application number: M020
New Kid on the BlockZINC OXIDEDimples Bath Co. LLC26f85758-820f-3f73-e063-6294a90a289d2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Spritz Face MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2b0f0b56-233f-4c6a-e063-6394a90aea6f2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Spritz Body MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2b0fe721-b92a-4181-e063-6394a90a846a2025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 56 Sunscreen Stick SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC92c4e4cb-aadc-26f4-e053-2995a90a03d52025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 56 Sunscreen Compact SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb8a4986d-c28f-c4f4-e053-2a95a90a71672025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC8f119447-045b-43f3-e053-2995a90aea772025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 75 Sunscreen Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb878ee3b-6897-3c4a-e053-2995a90afed72025-01-06WarningsExact 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