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

Intellishade Original SPF 45 by

Drug Labeling and Warnings

Intellishade Original SPF 45 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

ITO_carton_retail_IOC9_V4_OL.jpg

ITO_tube_retail_IOR5_V3_OL.jpg

Intellishade®
Original

anti-aging
tinted moisturizer
with sunscreen

Broad-Spectrum
SPF 45

NET WT 1.7 OZ | 48 g

Active ingredient           Purpose
Octinoxate 7.5% ............ Sunscreen
Octisalate 5% ................ Sunscreen
Titanium Dioxide 3.5%... 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, Jojoba Esters, Hydrogenated Starch Hydrolysate, Caprylic/Capric Triglyceride, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Butylene Glycol, Cetyl Dimethicone, Ethylhexyl Palmitate, Ethylhexyl Stearate, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Triethoxycaprylylsilane, Benzoic Acid, Sorbic 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® Original

ITO_pro_tube_IOP6_V2_OL.jpg

Intellishade®
Original

anti-aging
tinted moisturizer
with sunscreen

Broad-Spectrum
SPF 45

NET WT 8 OZ | 227 g

Active ingredient           Purpose
Octinoxate 7.5% ............ Sunscreen
Octisalate 5% ................ Sunscreen
Titanium Dioxide 3.5%... 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, Jojoba Esters, Hydrogenated Starch Hydrolysate, Caprylic/Capric Triglyceride, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Butylene Glycol, Cetyl Dimethicone, Ethylhexyl Palmitate, Ethylhexyl Stearate, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Triethoxycaprylylsilane, Benzoic Acid, Sorbic 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 untinted daily moisturizer with 100% mineral sunscreen

Broad Spectrum

SPF 50

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64651-7749
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE (UNII: 0UBP26S1LG)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
WHITE WAX (UNII: 7G1J5DA97F)
DIMETHICONE (UNII: 92RU3N3Y1O)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
YEAST (UNII: 3NY3SM6B8U)
BORON NITRIDE (UNII: 2U4T60A6YD)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
UBIDECARENONE (UNII: EJ27X76M46)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
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)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64651-7749-1	1 in 1 CARTON	07/09/2013
1		48 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 64651-7749-2	227 g in 1 TUBE; Type 0: Not a Combination Product	07/09/2013
3	NDC: 64651-7749-3	3 g in 1 TUBE; Type 0: Not a Combination Product	07/09/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/09/2013

Labeler - Revision, LLC (805995131)

Registrant - Revision, LLC (805995131)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LP		007317209	manufacture(64651-7749)