INTELLISHADE TRUPHYSICAL SPF 45- titanium dioxide, zinc oxide lotion

Intellishade TruPhysical SPF 45 by

Drug Labeling and Warnings

Intellishade TruPhysical SPF 45 by is a Otc medication manufactured, distributed, or labeled by Revision, LLC, Goodier Cosmetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

1.7oz Revision Intellishade® TruePhysical

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ITP_retail_tube_ITR6_V2_OL.jpg

Intellishade®
TruPhysical

anti-aging tinted
daily moisturizer

with 100% mineral sunscreen

Broad-Spectrum
SPF 45

Moisturize & Protect

Net Wt

1.7 Oz 48g

Active ingredient Purpose
Zinc Oxide 14.4% ......... Sunscreen
Titanium Dioxide 4.4% . 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 useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash occurs

Keep out of reach of children.If swallowed, get medical help or contact
a Poison Control Center right away.

Directions
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: Ask a doctor

Inactive ingredientsWater (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment, Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Glycerin, Hydrogenated Starch Hydrolysate, Butylene Glycol, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Acrylates/Dimethicone Copolymer, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Dimethicone/Vinyl Dimethicone Crosspolymer, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Leuconostoc/Radish Root Ferment Filtrate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Melanin, Phenoxyethanol, Silica, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Triethoxycaprylylsilane, Magnesium Sulfate, Iron Oxides (CI 77491, CI 77492, CI 77499)

Other information
protect this product from excessive heat and direct sun

Dist. by Revision, LP

Irving TX, 75063 Made in U.S.A.

8oz Revision Intellishade® Tru Physical

ITP_pro_tube_ITP6_V1_OL.jpg

Intellishade®

TruPhysical

Anti-aging tinted

daily moisturizer with

100% mineral sunscreen

Broad-Spectrum

SPF 45

Net Wt

8Oz 227g

Active ingredient Purpose
Zinc Oxide 14.4% ......... Sunscreen
Titanium Dioxide 4.4% . 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

When using this product keep out of eyes. Rinse wilth 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.

Do not used on damaged or broken skin

Directions
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: Ask a doctor

Inactive ingredients Water (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment, Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Glycerin, Hydrogenated Starch Hydrolysate, Butylene Glycol, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Acrylates/Dimethicone Copolymer, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Dimethicone/Vinyl Dimethicone Crosspolymer, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Leuconostoc/Radish Root Ferment Filtrate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Melanin, Phenoxyethanol, Silica, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Triethoxycaprylylsilane, Magnesium Sulfate, Iron Oxides (CI 77491, CI 77492, CI 77499)

Other information
protect this product from excessive heat and direct sun

Dist. by Revision, LP

Irving TX, 75063 Made in U.S.A.

DOSAGE & ADMINISTRATION

apply liberally 15 minutes before sun exposure
reapply at least every two hours
use a water resistant sunscreen if swimming or sweating

PURPOSE

Anti-aging tinted daily moisturizer with 100% mineral sunscreen

Broad Spectrum

SPF 45

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INTELLISHADE TRUPHYSICAL SPF 45 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64651-1003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SORBIC ACID (UNII: X045WJ989B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
THERMUS THERMOPHILUS (UNII: 415H64SACF)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WHITE WAX (UNII: 7G1J5DA97F)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
BORON NITRIDE (UNII: 2U4T60A6YD)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
UBIQUINONE Q2 (UNII: I7T5V2W47R)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CHLORPHENESIN (UNII: I670DAL4SZ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64651-1003-1	1 in 1 CARTON	03/05/2018
1		48 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 64651-1003-2	227 g in 1 TUBE; Type 0: Not a Combination Product	03/05/2018
3	NDC: 64651-1003-3	3 g in 1 TUBE; Type 0: Not a Combination Product	03/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/05/2018

Labeler - Revision, LLC (805995131)

Registrant - Revision, LLC (805995131)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LLC		007317209	manufacture(64651-1003)