IT COSMETICS BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER BROAD SPECTRUM 50 PLUS SUNSCREEN ALL SHADES- titanium dioxide and zinc oxide lotion

it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All Shades by

Drug Labeling and Warnings

it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All Shades by is a Otc medication manufactured, distributed, or labeled by IT COSMETICS, LLC, Beauty Manufacturing Solutions Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium dioxide 8.9%

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

● shake well before 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

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, phenoxyethanol, citrus limon (lemon) peel oil, sorbitan isostearate, tocopheryl acetate, 1,2-hexanediol, citrus aurantium bergamia (bergamot) fruit oil, disodium EDTA, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) oil, pinus sylvestris leaf oil, niacinamide, punica granatum seed oil, vitis vinifera (grape) seed oil, cholesterol, cholesteryl oleyl carbonate, persea gratissima (avocado) oil, polymethylsilsesquioxane, anthemis nobilis flower water, lactobacillus/dipteryx odorata seed ferment filtrate, lactobacillus/pumpkin ferment extract, linalool, panax ginseng root extract, avena sativa (oat) kernel extract, eucalyptus globulus leaf oil, saccharomyces/rice ferment filtrate, lactobacillus/kelp ferment filtrate, cholesteryl isostearate, citral, cholesteryl chloride, cholesteryl nonanoate, curcuma longa (turmeric) root extract, perfluorohexane, glycerin, leuconostoc/radish root ferment filtrate, magnolia kobus bark extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, camellia sinensis leaf extract, glycine soja (soybean) sprout extract, perfluorodecalin, silk extract, hydrolyzed silk, perfluoromethylcyclopentane, silica, steareth-20, citric acid, saccharum officinarum (sugarcane) extract, cocos nucifera (coconut) fruit extract, hydrolyzed collagen, 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, sodium benzoate, chrysanthemum indicum flower extract, potassium sorbate, BHT, diamond powder, lactobacillus/honeysuckle flower/licorice root/morus alba root/pueraria lobata root/schisandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, aloe barbadensis leaf extract, caprylhydroxamic acid, olea europaea (olive) leaf extract, artemisia princeps leaf extract, cinnamomum cassia bark extract, pueraria lobata root extract, diospyros kaki leaf extract, morus alba fruit extract, chlorhexidine digluconate, n-hydroxysuccinimide, biotin, thiamine HCL, niacin, folic acid, retinyl palmitate, carnitine HCL, riboflavin, tocopherol, ascorbic acid, pantothenic acid, sodium citrate, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7; may contain: titanium dioxide, iron oxides

Questions or comments?

Call 800-620-3956

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IT COSMETICS BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER BROAD SPECTRUM 50 PLUS SUNSCREEN ALL SHADES 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69259-2888
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	89 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	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)
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)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ORANGE OIL (UNII: AKN3KSD11B)
LIME OIL (UNII: UZH29XGA8G)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
NIACINAMIDE (UNII: 25X51I8RD4)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE)
AVOCADO OIL (UNII: 6VNO72PFC1)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ASIAN GINSENG (UNII: CUQ3A77YXI)
OAT (UNII: Z6J799EAJK)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464)
CITRAL (UNII: T7EU0O9VPP)
CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39)
CHOLESTERYL NONANOATE (UNII: 4313O7P4XW)
TURMERIC (UNII: 856YO1Z64F)
PERFLEXANE (UNII: FX3WJ41CMX)
GLYCERIN (UNII: PDC6A3C0OX)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
MAGNOLIA KOBUS BARK (UNII: 54LVP49595)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SOYBEAN (UNII: L7HT8F1ZOD)
PERFLUNAFENE (UNII: 54A06VV62N)
PERFLUOROMETHYLCYCLOPENTANE (UNII: 8S014W4T75)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
STEARETH-20 (UNII: L0Q8IK9E08)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUGARCANE (UNII: 81H2R5AOH3)
COCONUT (UNII: 3RT3536DHY)
ADZUKI BEAN (UNII: 31GYU1X0FP)
LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DIAMOND (UNII: 6GRV67N0U2)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)
CHINESE CINNAMON (UNII: WS4CQ062KM)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)
WHITE MULBERRY (UNII: MN25R0HH5A)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
BIOTIN (UNII: 6SO6U10H04)
THIAMINE HYDROCHLORIDE (UNII: M572600E5P)
NIACIN (UNII: 2679MF687A)
FOLIC ACID (UNII: 935E97BOY8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
LEVOCARNITINE HYDROCHLORIDE (UNII: J3Y5E6IKS3)
RIBOFLAVIN (UNII: TLM2976OFR)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PANTOTHENIC ACID (UNII: 19F5HK2737)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
CHRYSIN (UNII: 3CN01F5ZJ5)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69259-2888-1	1 in 1 CARTON	11/01/2020
1		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	11/01/2020

Labeler - IT COSMETICS, LLC (962591793)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(69259-2888)