IT COSMETICS BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL FREE MATTE BROAD SPECTRUM 50 PLUS SUNSCREEN- titanium dioxide and zinc oxide lotion

it cosmetics Bye Bye Foundation Full Coverage Moisturizer Oil Free Matte Broad Spectrum 50 Plus Sunscreen by

Drug Labeling and Warnings

it cosmetics Bye Bye Foundation Full Coverage Moisturizer Oil Free Matte Broad Spectrum 50 Plus Sunscreen 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 7.4%

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, dimethicone, butylene glycol dicaprylate/dicaprate, butylene glycol, cyclopentasiloxane, dimethicone/vinyl dimethicone crosspolymer, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, snail secretion filtrate, sodium chloride, bis-diglyceryl polyacyladipate-2, aluminum hydroxide, stearic acid, disteardimonium hectorite, sorbitan isostearate, polyglyceryl-4 isostearate, hexyl laurate, triethoxycaprylylsilane, triethyl citrate, ethyl hexanediol, sodium benzoate, phenoxyethanol, potassium sorbate, polymethylsilsesquioxane, tocopheryl acetate, disodium EDTA, canadian colloidal clay, moroccan lava clay, avena sativa (oat) kernel extract, glycerin, niacinamide, curcuma longa (turmeric) root extract, sulfur, cholesterol, anthemis nobilis flower water, perfluorohexane, persea gratissima (avocado) fruit extract, maltodextrin, 1,2-hexanediol, vitis vinifera (grape) seed extract, camellia sinensis leaf extract, salix alba (willow) bark extract, magnolia kobus bark extract, chrysanthemum indicum flower extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, glycine soja (soybean) sprout extract, perfluorodecalin, silk extract, hydrolyzed silk, aloe barbadensis leaf extract, perfluoromethylcyclopentane, citric 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, steareth-20, melaleuca alternifolia (tea tree) flower/leaf/stem extract, punica granatum fruit juice, hydrolyzed collagen, ethylhexylglycerin, charcoal powder, lactobacillus/honeysuckle flower/licorice root/morus alba root/pueraria lobata root/schisandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, chlorhexidine digluconate, n-hydroxysuccinimide, sodium citrate, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7, biotin; may contain: iron oxides, titanium dioxide

Questions or comments?

Call 800-620-3956

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IT COSMETICS BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL FREE MATTE BROAD SPECTRUM 50 PLUS SUNSCREEN 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69259-4244
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	74 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)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ETHOHEXADIOL (UNII: M9JGK7U88V)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OAT (UNII: Z6J799EAJK)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
TURMERIC (UNII: 856YO1Z64F)
SULFUR (UNII: 70FD1KFU70)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
PERFLEXANE (UNII: FX3WJ41CMX)
AVOCADO (UNII: SDS87L369F)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SALIX ALBA BARK (UNII: 205MXS71H7)
MAGNOLIA KOBUS BARK (UNII: 54LVP49595)
CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SOYBEAN (UNII: L7HT8F1ZOD)
PERFLUNAFENE (UNII: 54A06VV62N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PERFLUOROMETHYLCYCLOPENTANE (UNII: 8S014W4T75)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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)
STEARETH-20 (UNII: L0Q8IK9E08)
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)
POMEGRANATE JUICE (UNII: 99S671U9KB)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
CHRYSIN (UNII: 3CN01F5ZJ5)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
BIOTIN (UNII: 6SO6U10H04)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69259-4244-1	1 in 1 CARTON	06/01/2019
1		30 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	06/01/2019

Labeler - IT COSMETICS, LLC (962591793)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(69259-4244)