INTELLISHADE MATTE SPF 45- octinoxate, octisalate, titanium dioxide, zinc oxide cream

Intellishade Matte SPF 45 by

Drug Labeling and Warnings

Intellishade Matte 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® Matte

ITM_retail_carton_IMC5

ITM_retail_tube_IMR5

Intellishade®
Matte

anti-aging
tinted moisturizer
with sunscreen

Broad-Spectrum
SPF 45

NET WT 1.7 OZ | 48 g

Active ingredient ........ Purpose

Octinoxate 5.5% ........... Sunscreen
Octisalate 3.5% ............. Sunscreen
Titanium Dioxide 4% ...... Sunscreen
Zinc Oxide 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 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), Cyclopentasiloxane, Hydrogenated Starch Hydrolysate, Caprylic/Capric Triglyceride, Cetearyl Olivate, Glycerin, Butylene Glycol, Sorbitan Olivate, Dimethicone, Aloe Barbadensis Leaf Juice, Isodecyl Neopentanoate, Diisopropyl Sebacate, Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Glyceryl Stearate, Tocopherol, Allantoin, Lauryl Lactate, Squalane, Yeast Extract (Faex), Plankton Extract, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Silica, Lecithin, Cetyl Alcohol, PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Palmitoyl Tripeptide-5, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Glyceryl Isostearate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Tocopheryl Acetate, Polyhydroxystearic Acid, Boron Nitride, Phenoxyethanol, Chlorphenesin, Hydroxyethylcellulose, Xanthan Gum, Magnesium Chloride, Triethoxycaprylylsilane, Sorbic Acid, Benzoic Acid, 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® Matte

ITM_pro_tube_IMP6

PROFESSIONAL

Intellishade®
Matte

anti-aging
tinted moisturizer
with sunscreen

Broad-Spectrum
SPF 45

NET WT 8 OZ | 227 g

Active ingredient ........ Purpose

Octinoxate 5.5% ........... Sunscreen
Octisalate 3.5% ............. Sunscreen
Titanium Dioxide 4% ...... Sunscreen
Zinc Oxide 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 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), Cyclopentasiloxane, Hydrogenated Starch Hydrolysate, Caprylic/Capric Triglyceride, Cetearyl Olivate, Glycerin, Butylene Glycol, Sorbitan Olivate, Dimethicone, Aloe Barbadensis Leaf Juice, Isodecyl Neopentanoate, Diisopropyl Sebacate, Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Glyceryl Stearate, Tocopherol, Allantoin, Lauryl Lactate, Squalane, Yeast Extract (Faex), Plankton Extract, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Silica, Lecithin, Cetyl Alcohol, PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Palmitoyl Tripeptide-5, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Glyceryl Isostearate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Tocopheryl Acetate, Polyhydroxystearic Acid, Boron Nitride, Phenoxyethanol, Chlorphenesin, Hydroxyethylcellulose, Xanthan Gum, Magnesium Chloride, Triethoxycaprylylsilane, Sorbic Acid, Benzoic Acid, 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 sunscreen

Broad Spectrum

SPF 45

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INTELLISHADE MATTE SPF 45 
octinoxate, octisalate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64651-7603
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN OLIVATE (UNII: MDL271E3GR)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TOCOPHEROL (UNII: R0ZB2556P8)
ALLANTOIN (UNII: 344S277G0Z)
LAURYL LACTATE (UNII: G5SU0BFK7O)
SQUALANE (UNII: GW89575KF9)
YEAST (UNII: 3NY3SM6B8U)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
UBIDECARENONE (UNII: EJ27X76M46)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
BORON NITRIDE (UNII: 2U4T60A6YD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
XANTHAN GUM (UNII: TTV12P4NEE)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SORBIC ACID (UNII: X045WJ989B)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64651-7603-1	1 in 1 CARTON	06/22/2013
1		48 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 64651-7603-2	227 g in 1 TUBE; Type 0: Not a Combination Product	06/22/2013
3	NDC: 64651-7603-3	3 g in 1 TUBE; Type 0: Not a Combination Product	06/22/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/22/2013

Labeler - Revision, LLC (805995131)

Registrant - Revision, LLC (805995131)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LLC		007317209	manufacture(64651-7603)