ALL PHYSICAL SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide lotion

All Physical Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

All Physical Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Goodier Cosmetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Intellishade®
TruPhysical™

anti-aging tinted
daily moisturizer with
100% mineral sunscreen

Broad-Spectrum
SPF 45

SPL UNCLASSIFIED SECTION

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

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

INDICATIONS & USAGE

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

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.

INSTRUCTIONS FOR USE

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 INGREDIENT

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.

QUESTIONS

Other information
protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

1.7oz Intellishade® TruPhysical™

8oz Intellishade® TruPhysical™

3gm Sampler Intellishade® TruPhysical™

INGREDIENTS AND APPEARANCE

ALL PHYSICAL SUNSCREEN BROAD SPECTRUM SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10477-1003
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
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
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10477-1003-1	1 in 1 CARTON	03/05/2018
1		48 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10477-1003-2	227 g in 1 TUBE; Type 0: Not a Combination Product	03/05/2018
3	NDC: 10477-1003-3	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 not final	part352	03/05/2018

Labeler - Goodier Cosmetics LLC (007317209)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LLC		007317209	manufacture(10477-1003)