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 246 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ulta Beauty Tinted Moisturizer Cream Spf 24 MediumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbc0ff10-fb2f-e637-e053-6294a90a0c292024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 DeepAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984c64f-eaac-ecb6-e063-6394a90aeb122024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 TanAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984a014-a56f-753b-e063-6294a90a13f52024-12-26WarningsExact identifier
application number: M020
Julep No Excuses Gel for Face SPF40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation298404c4-d4be-7395-e063-6294a90a86bf2024-12-26WarningsExact identifier
application number: M020
Cover FX Invisible Primer SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2983dd7c-7ca7-e952-e063-6394a90a30982024-12-26WarningsExact identifier
application number: M020
3LAB WW DAY SPF40 BROAD SPECTRUMHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE3LAB, INC2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e2024-12-26WarningsExact identifier
application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation30b224f0-43f1-4c79-839e-3a970e4be3a52024-12-26WarningsExact identifier
application number: M020
CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREENHOMOSALATE, OCTISALATE, AND AVOBENZONECLINIQUE LABORATORIES LLCf4fe22b3-ccf2-4d67-8d20-5b5d3b69b4442024-12-25WarningsExact identifier
application number: M020
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLCee7e2ded-b850-4e15-96a6-556111e521872024-12-25WarningsExact identifier
application number: M020
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd1a3d76f-16dd-4533-8144-9a3175f6e15f2024-12-25WarningsExact identifier
application number: M020
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15TITANIUM DIOXIDEESTEE LAUDER INCa04a9aaa-fa0f-4dde-a7a5-c4c561cc51b12024-12-25WarningsExact identifier
application number: M020
ESTEE LAUDER MULTI-DEFENSE AQUA UV gel BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEESTEE LAUDER INC0770e251-95d0-43de-88f1-bc0a29811e4e2024-12-25WarningsExact identifier
application number: M020
MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMAKEUP ART COSMETICSc26ef380-1309-4a41-862f-eb319d38673d2024-12-25WarningsExact identifier
application number: M020
STUDIO FIX FLUID SPF 15 BROAD SPECTRUMOCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICSff48435d-245a-4037-9afb-caee83c4c4152024-12-25WarningsExact identifier
application number: M020
ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.0fe63edf-7a49-4b33-88f1-f480f889d1942024-12-25WarningsExact identifier
application number: M020
DR. ANDREW WEIL FOR ORIGINS MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING oil FREE MOISTURIZER BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.8e8c495e-d439-4735-a7cc-b44081b75b272024-12-25WarningsExact identifier
application number: M020
VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15AVOBENZONE, OCTISALATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.0fac5204-df18-4774-bb53-115513cb7ff02024-12-25WarningsExact identifier
application number: M020
LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INC66e48ce0-9a5b-4250-b07b-1622b3814c3e2024-12-25WarningsExact identifier
application number: M020
ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC2f93580c-c8e9-4822-91bf-a749cf4deb4e2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b14a17-cab9-1b3e-e063-6394a90afe5d2024-12-25WarningsExact 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