Intellishade TruPhysical SPF 45

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]

INTELLISHADE TRUPHYSICAL SPF 45- titanium dioxide, zinc oxide lotion 
Revision, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Intellishade TruPhysical SPF 45

Intellishade®
TruPhysical™


anti-aging tinted
daily moisturizer with
100% mineral sunscreen


Broad-Spectrum
SPF 45

Intellishade®
TruPhysical™


A breakthrough daily moisturizer with anti-aging technology that leaves skin instantly glowing and
appearing more youthful and brighter over time.

Helps reduce and prevent visible signs of aging with a powerful blend of 3 bioavailable peptides,
botanical extracts and antioxidants.

Provides broad spectrum UV protection with ground-breaking,
100% all-mineral technology and no hidden chemical sunscreens.

Universal tint blends with all skin tones for a healthy, naturally beautiful look.

Dist. by Revision, LLC – ITC1
Irving, TX 75063 Made in U.S.A.

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 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
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, Hydrogenated
Starch Hydrolysate, Glycerin, Butylene Glycol, Aloe Barbadensis Leaf Juice, Betula
Alba (White Birch) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract, Plankton
Extract, Beeswax, 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 Tri-uoroacetate, Yeast Extract (Faex), Boron
Nitride, Epigallocatechin Gallate, Ubiquinone, Jojoba Bean Meal, Melanin, Phenoxyethanol,
Silica, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride,
Benzoic Acid, Sorbic Acid, Triethoxycaprylylsilane, Magnesium Sulfate, Iron Oxides.

Other information
protect this product from excessive heat and direct sun

1.7oz TruPhysical

1.7oz Intellishade® TruPhysical™

8oz TruPhysical

8oz Intellishade® TruPhysical™

3gm TruPhysical

3gm Sampler Intellishade® TruPhysical™

INTELLISHADE TRUPHYSICAL SPF 45 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64651-1003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBIC ACID (UNII: X045WJ989B)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64651-1003-11 in 1 CARTON03/05/2018
148 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 64651-1003-2227 g in 1 TUBE; Type 0: Not a Combination Product03/05/2018
3NDC: 64651-1003-33 g in 1 TUBE; Type 0: Not a Combination Product03/05/2018
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/05/2018
Labeler - Revision, LLC (805995131)
Registrant - Revision, LLC (805995131)
Establishment
NameAddressID/FEIBusiness Operations
Goodier Cosmetics LLC007317209manufacture(64651-1003)

Revised: 2/2023
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.