INTELLISHADE TRUPHYSICAL CLEAR SPF 50- titanium dioxide, zinc oxide cream

Intellishade TruPhysical Clear SPF 50 by

Drug Labeling and Warnings

Intellishade TruPhysical Clear SPF 50 by is a Otc medication manufactured, distributed, or labeled by Revision, LLC, Goodier Cosmetics LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

1.7oz Revision Intellishade® Original

ITPC_carton_retail_ITCC3_V1_OL (1)

ITPC_pro_tube_ITCP3_V2_OL (1)

Intellishade®
Original

anti-aging
tinted moisturizer
with sunscreen

Broad-Spectrum
SPF 45

NET WT 1.7 OZ | 48 g

Active ingredient Purpose
Titanium Dioxide 2.5%........ Sunscreen
Zinc Oxide 15.2% ............... 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 doctorif rash 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 ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment, Diisopropyl Adipate, Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Bacillus Lysate, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Glycerin, Hydrogenated Starch Hydrolysate, Butylene Glycol, Polyhydroxystearic Acid, Glyceryl Isostearate, Silica, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, 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, Glyceryl Behenate/Eicosadioate, Chlorphenesin, Stearoyl Glutamic Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Magnesium Sulfate, Iron Oxides (CI 77492)

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® Original

ITPC_retail_tube_ITCR4_V1_OL (1)

Intellishade®
Original

anti-aging
tinted moisturizer
with sunscreen

Broad-Spectrum
SPF 45

NET WT 8 OZ | 227 g

Active ingredient Purpose
Titanium Dioxide 2.5%........ Sunscreen
Zinc Oxide 15.2% ............... 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 doctorif rash 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 ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment, Diisopropyl Adipate, Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Bacillus Lysate, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Glycerin, Hydrogenated Starch Hydrolysate, Butylene Glycol, Polyhydroxystearic Acid, Glyceryl Isostearate, Silica, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, 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, Glyceryl Behenate/Eicosadioate, Chlorphenesin, Stearoyl Glutamic Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Magnesium Sulfate, Iron Oxides (CI 77492)

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 untinted daily moisturizer with 100% mineral sunscreen

Broad Spectrum

SPF 50

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INTELLISHADE TRUPHYSICAL CLEAR SPF 50 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64651-1226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
THERMUS THERMOPHILUS (UNII: 415H64SACF)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
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)
TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE (UNII: 0UBP26S1LG)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
BORON NITRIDE (UNII: 2U4T60A6YD)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
UBIDECARENONE (UNII: EJ27X76M46)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
SORBIC ACID (UNII: X045WJ989B)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
CHLORPHENESIN (UNII: I670DAL4SZ)
STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64651-1226-1	1 in 1 CARTON	03/01/2024
1		48 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 64651-1226-2	227 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2024
3	NDC: 64651-1226-3	3 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2024

Labeler - Revision, LLC (805995131)

Registrant - Revision, LLC (805995131)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LP		007317209	manufacture(64651-1226)