YOUR SKIN BUT BETTER FAIR- titanium dioxide and zinc oxide cream

YOUR SKIN BUT BETTER by

Drug Labeling and Warnings

YOUR SKIN BUT BETTER by is a Otc medication manufactured, distributed, or labeled by IT COSMETICS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

IT COSMETICS®
YOUR SKIN BUT BETTER (FAIR)

Net Wt. 32 ml / 1.08 fl.oz

Drug Facts

Active ingredient              Purpose
Titanium dioxide 9.0%      Sunscreen
Zinc oxide 6.3%               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 Poison Control Center right away.

Directions
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hour.
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.
Questions? Call 800.620.3950

Inactive Ingredients
Butylene Glycol, Phenyl Trimethicone, Dimethicone, Snail Secretion Filtrate, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Magnesium Sulfate, Polyglyceryl-4 Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Hexyl Laurate, Stearic Acid, Calcium Stearate, Caprylyl Glycol, Triethoxycaprylylsilane, Ethylhexylglycerin, Phenoxyethanol, Citrus Medica Limonum (Lemon) Peel Oil, Tocopheryl Acetate, Sorbitan Isostearate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, 1,2-Hexanediol, Water, Disodium EDTA, Citrus aurantium dulcis (orange) peel essential oil, Citrus Aurantifolia (Lime) Essential Oil, Vitis Vinifera (Grape) Seed Oil, Punica Granatum Seed Oil, Pinus Sylvestris Leaf Essential Oil, Persea Gratissima (Avocado) Oil, Niacinamide, Citrus Grandis (Grapefruit) Peel Oil, Anthemis Nobilis Flower Water, Lactobacillus/Honeysuckle Flower/Licorice Root/Morus Alba Root/Pueraria Lobata Root/Schizandra Chinensis Fruit/Scutellaria Baicalensis Root/Sophora Japonica Flower Extract Ferment Filtrate, Perfluorohexane, Olea Europaea (Olive) Leaf Extract, Glycerin, Eucalyptus Essential Oil, Cholesterol, Camellia Sinensis Leaf Extract, Chrysanthemum Indicum flower Extract, Pueraria Lobata Root Extract, Perfluorodecalin, Morus Alba Fruit Extract, Magnolia Kobus Bark Extract, Glycine Soja (Soybean) Sprout Extract, Diospyros Kaki Leaf Extract, Cinnamomum Cassia Bark Extract, Artemisia Princeps Leaf , Tocopherol, Thiamine HCl, Riboflavin, Retinyl Palmitate, Pantothenic Acid, Palmitoyl Oligopeptide, Niacin, Folic Acid, Chrysin, Carnitine HCl, Biotin, Ascorbic Acid, Palmitoyl Tetrapeptide-7, Chlorhexidine Digluconate, Iron Oxides (CI 77492, CI 77491, CI 77499).

32 mL Pack size

INGREDIENTS AND APPEARANCE

YOUR SKIN BUT BETTER  FAIR
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69259-1101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9.0 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Stearic Acid (UNII: 4ELV7Z65AP)
Calcium Stearate (UNII: 776XM7047L)
Caprylyl Glycol (UNII: 00YIU5438U)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Ethylhexylglycerin (UNII: 147D247K3P)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Phenoxyethanol (UNII: HIE492ZZ3T)
1,2-Hexanediol (UNII: TR046Y3K1G)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
LIME OIL (UNII: UZH29XGA8G)
GRAPE SEED OIL (UNII: 930MLC8XGG)
Punica Granatum Seed Oil (UNII: 0UI45XV0T6)
AVOCADO OIL (UNII: 6VNO72PFC1)
Niacinamide (UNII: 25X51I8RD4)
WHITE PINE OIL (UNII: HA5CX6676U)
GRAPEFRUIT OIL (UNII: YR377U58W9)
Cholesterol (UNII: 97C5T2UQ7J)
Glycerin (UNII: PDC6A3C0OX)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SOYBEAN OIL (UNII: 241ATL177A)
Pentafluoropropane (UNII: TA9UOF49CY)
TURMERIC (UNII: 856YO1Z64F)
Steareth-20 (UNII: L0Q8IK9E08)
SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY)
HYALURONIC ACID (UNII: S270N0TRQY)
OATMEAL (UNII: 8PI54V663Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Sodium Benzoate (UNII: OJ245FE5EU)
Potassium Sorbate (UNII: 1VPU26JZZ4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
N-Hydroxysuccinimide (UNII: MJE3791M4T)
HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Tocopherol (UNII: R0ZB2556P8)
THIAMINE HYDROCHLORIDE (UNII: M572600E5P)
Riboflavin (UNII: TLM2976OFR)
RETINOL (UNII: G2SH0XKK91)
Pantothenic Acid (UNII: 19F5HK2737)
Palmitoyl Oligopeptide (UNII: HO4ZT5S86C)
Niacin (UNII: 2679MF687A)
Folic Acid (UNII: 935E97BOY8)
Chrysin (UNII: 3CN01F5ZJ5)
CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9)
Biotin (UNII: 6SO6U10H04)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)
CHLORHEXIDINE (UNII: R4KO0DY52L)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

Product Characteristics
Color	brown (FAIR)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69259-1101-3	32 mL in 1 TUBE; Type 0: Not a Combination Product	07/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/27/2017

Labeler - IT COSMETICS, LLC (962591793)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(69259-1101)