IT COSMETICS BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER WITH 3D SKIN FLEX BROAD SPECTRUM SPF 50 PLUS UVA UVB PHYSICAL SUNSCREEN ALL SHADES- titanium dioxide and zinc oxide lotion

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

Drug Labeling and Warnings

it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All Shades by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA, Inc., Beauty Manufacturing Solutions Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium dioxide 9%

Zinc oxide  6.3%

Purpose

Sunscreen

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk,

    regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

   ● limit time in the sun, especially from 10 a.m. – 2 p.m.

   ● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

G2026415: water, phenyl trimethicone, dimethicone, butylene glycol, butylene glycol dicaprylate/dicaprate, orbignya oleifera seed oil, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, cyclopentasiloxane, snail secretion filtrate, aluminum hydroxide, magnesium sulfate, polyglyceryl-4 isostearate, stearic acid, cyclohexasiloxane, dimethicone/vinyl dimethicone crosspolymer, hexyl laurate, calcium stearate, caprylyl glycol, triethoxycaprylylsilane, ethyl hexanediol, ethylhexylglycerin, limonene, citrus limon (lemon) peel oil, sorbitan isostearate, tocopheryl acetate, phenoxyethanol, 1,2-hexanediol, citrus aurantium bergamia (bergamot) fruit oil, adenosine, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) oil, pinus sylvestris leaf oil, niacinamide, polymethylsilsesquioxane, lactobacillus/dipteryx odorata seed ferment filtrate, lactobacillus/pumpkin ferment extract, propylene glycol, saccharomyces/xylinum/black tea ferment, linalool, glycerin, eucalyptus globulus leaf oil, saccharomyces/rice ferment filtrate, lactobacillus/kelp ferment filtrate, citral, hydrolyzed collagen, leuconostoc/radish root ferment filtrate, panax ginseng root extract, cocos nucifera (coconut) fruit extract, hydroxyethylcellulose, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, camellia sinensis leaf extract, silk extract, hydrolyzed silk, sodium citrate, citric acid, steareth-20, potassium sorbate, saccharomyces/camellia sinensis extract ferment filtrate, bacillus/cordyceps sinensis/ganoderma lucidum/inonotus obliquus/lentinus edodes/phellinus linteus/schizophyllum commune/tricholoma matsutake extract ferment filtrate, phaseolus angularis seed extract, lactobacillus ferment, lactobacillus/centella asiatica/gleditsia sinensis thorn/houttuynia cordata extract/phellodendron amurense bark/polygonum cuspidatum root/prunella vulgaris/torilis japonica extract ferment filtrate, lactobacillus/rice ferment filtrate, xanthan gum, diamond powder, olea europaea (olive) leaf extract, chlorhexidine digluconate, n-hydroxysuccinimide, biotin, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7. May contain: iron oxides, titanium dioxide.

Questions or comments?

Call 800-620-3950

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IT COSMETICS BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER WITH 3D SKIN FLEX BROAD SPECTRUM SPF 50 PLUS UVA UVB PHYSICAL SUNSCREEN ALL SHADES 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-334
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
BABASSU OIL (UNII: 8QSB4M5477)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SNAIL SECRETION FILTRATE (UNII: BPB1U0R467)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
STEARIC ACID (UNII: 4ELV7Z65AP)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CALCIUM STEARATE (UNII: 776XM7047L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHOHEXADIOL (UNII: M9JGK7U88V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LEMON OIL (UNII: I9GRO824LL)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
ADENOSINE (UNII: K72T3FS567)
ORANGE OIL (UNII: AKN3KSD11B)
LIME OIL (UNII: UZH29XGA8G)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
glycerin (UNII: PDC6A3C0OX)
EUCALYPTUS GLOBULUS LEAF OIL (UNII: 2R04ONI662)
CITRAL (UNII: T7EU0O9VPP)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
ASIAN GINSENG (UNII: CUQ3A77YXI)
COCOS NUCIFERA (COCONUT) FRUIT (UNII: 3RT3536DHY)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID (UNII: 2968PHW8QP)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ADZUKI BEAN (UNII: 31GYU1X0FP)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
XANTHAN GUM (UNII: TTV12P4NEE)
DIAMOND POWDER (UNII: 6GRV67N0U2)
OLEA EUROPAEA (OLIVE) LEAF (UNII: MJ95C3OH47)
CHLORHEXIDINE DIGLUCONATE (UNII: MOR84MUD8E)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
BIOTIN (UNII: 6SO6U10H04)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
Chrysin (UNII: 3CN01F5ZJ5)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-334-01	1 in 1 CARTON	11/15/2025
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82046-334-02	1 in 1 CARTON	11/15/2025
2		75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/15/2025

Labeler - L'Oreal USA, Inc. (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(82046-334)