INTELLISHADE CLEAR SPF 50- avobenzone, homosalate, octinoxate, octisalate cream

Intellishade Clear SPF 50 by

Drug Labeling and Warnings

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

Drug Details [pdf]

Revision Siincare Intellishade Clear Spectrum SPF 50 1.7 oz

ITC_carton_retail_ICC2_V5_OL

ITC_retail_tube_ICR4_V1_OL

Anti-aging untinted

daily moisturizer

with sunscreen

Broad-Spectrum
SPF 50

Moisturize + Protect

NET WT 1.7 OZ | 48 g

Active ingredient          Purpose

Avobenzone 3% ........... Sunscreen
Homosalate 3% ............ Sunscreen
Octinoxate 7.5% .......... Sunscreen
Octisalate 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 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

Water (Aqua), C12-15 Alkyl Ethylhexanoate, Cyclopentasiloxane, Hydrogenated Starch Hydrolysate, Cetearyl Alcohol, Polyglyceryl-3 Methylglucose Distearate, Boron Nitride, Glycerin, Butylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Tetrahexyldecyl Ascorbate, Yeast Extract (Faex), Camellia Sinensis Leaf Extract, Epigallocatechin Gallate, Betula Alba Bark Extract, Biosaccharide Gum-1, Ubiquinone, Cetyl Dimethicone, Palmitoyl Tripeptide-5, Squalane, Sodium Hyaluronate, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Punica Granatum Fruit Extract, Plankton Extract, Steareth-20, Tocopheryl Acetate, Allantoin, Lecithin, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Glyceryl Caprylate, Carbomer, Leuconostoc/Radish Root Ferment Filtrate, Tocopherol, Steareth-10, Simmondsia Chinensis (Jojoba) Meal Extract, Disodium EDTA, Magnesium Chloride, Potassium Sorbate, Fragrance (Parfum), Benzyl Benzoate, Citronellol, Hexamethylindanopyran, Hexyl Cinnamal, Limonene, Linalool, Linalyl Acetate, Tetramethyl Acetyloctahydronaphthalenes

Other information
protect this product from excessive heat and direct sun

Dist. by Revision, LP
Irving, TX 75063 Made in U.S.A.

Revision Siincare Intellishade Clear Spectrum SPF 50 8 oz

ITC_pro_tube_ICP4

Anti-aging untinted

daily moisturizer

with sunscreen

Broad-Spectrum
SPF 50

Moisturize + Protect

NET WT 1.7 OZ | 48 g

Active ingredient Purpose

Avobenzone 3% ........... Sunscreen
Homosalate 3% ............ Sunscreen
Octinoxate 7.5% .......... Sunscreen
Octisalate 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 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

Water (Aqua), C12-15 Alkyl Ethylhexanoate, Cyclopentasiloxane, Hydrogenated Starch Hydrolysate, Cetearyl Alcohol, Polyglyceryl-3 Methylglucose Distearate, Boron Nitride, Glycerin, Butylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Tetrahexyldecyl Ascorbate, Yeast Extract (Faex), Camellia Sinensis Leaf Extract, Epigallocatechin Gallate, Betula Alba Bark Extract, Biosaccharide Gum-1, Ubiquinone, Cetyl Dimethicone, Palmitoyl Tripeptide-5, Squalane, Sodium Hyaluronate, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Punica Granatum Fruit Extract, Plankton Extract, Steareth-20, Tocopheryl Acetate, Allantoin, Lecithin, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Glyceryl Caprylate, Carbomer, Leuconostoc/Radish Root Ferment Filtrate, Tocopherol, Steareth-10, Simmondsia Chinensis (Jojoba) Meal Extract, Disodium EDTA, Magnesium Chloride, Potassium Sorbate, Fragrance (Parfum), Benzyl Benzoate, Citronellol, Hexamethylindanopyran, Hexyl Cinnamal, Limonene, Linalool, Linalyl Acetate, Tetramethyl Acetyloctahydronaphthalenes

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 sunscreen

Broad Spectrum

SPF 50

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INTELLISHADE CLEAR SPF 50 
avobenzone, homosalate, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64651-7720
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	4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BORON NITRIDE (UNII: 2U4T60A6YD)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
YEAST (UNII: 3NY3SM6B8U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
UBIDECARENONE (UNII: EJ27X76M46)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
SQUALANE (UNII: GW89575KF9)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073)
POMEGRANATE (UNII: 56687D1Z4D)
STEARETH-20 (UNII: L0Q8IK9E08)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARETH-10 (UNII: FD0913P475)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64651-7720-1	1 in 1 CARTON	06/26/2013
1		48 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 64651-7720-2	227 g in 1 TUBE; Type 0: Not a Combination Product	06/26/2013
3	NDC: 64651-7720-3	3 g in 1 TUBE; Type 0: Not a Combination Product	06/26/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/26/2013

Labeler - Revision, LLC (805995131)

Registrant - Revision, LLC (805995131)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LLC		007317209	manufacture(64651-7720)