TINTED MOISTURIZER BROAD-SPECTRUM SPF 45- octinoxate, octisalate, titanium dioxide, zinc oxide cream

Tinted Moisturizer Broad-Spectrum SPF 45 by

Drug Labeling and Warnings

Tinted Moisturizer Broad-Spectrum SPF 45 by is a Otc medication manufactured, distributed, or labeled by Goodier Cosmetics LLC, Goodier Cosmetics LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

1.7oz Revision Intellishade® Original

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 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), Cyclopentasiloxane, Jojoba Esters, Caprylic/Capric Triglyceride, Ethylhexyl Stearate, Cetyl PEG/PPG-10/1
Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sorbitol, Glycerin, Butylene Glycol, Cetyl Dimethicone, Aloe
Barbadensis Leaf Juice, Betula Alba (White Birch) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,
Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5,
Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl
Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate,
Ubiquinone, Jojoba Bean Meal, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic
Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Iron Oxides.

Other information
protect this product from excessive heat and direct sun

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

1.7oz Revercel Triple Duty

triple duty
sunscreen

broad spectrum
spf 45
sheer tint

net wt. 1.7oz. | 48g

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 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), Cyclopentasiloxane, Jojoba Esters, Caprylic/Capric Triglyceride, Ethylhexyl Stearate, Cetyl PEG/PPG-10/1
Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sorbitol, Glycerin, Butylene Glycol, Cetyl Dimethicone, Aloe
Barbadensis Leaf Juice, Betula Alba (White Birch) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,
Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5,
Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl
Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate,
Ubiquinone, Jojoba Bean Meal, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic
Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Iron Oxides.

Other information
protect this product from excessive heat and direct sun

Made in the USA
Distributed by Revercel LLC
Campbell, CA 95008

8oz Revision Intellishade® Original

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 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), Cyclopentasiloxane, Jojoba Esters, Caprylic/Capric Triglyceride, Ethylhexyl Stearate, Cetyl PEG/PPG-10/1
Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sorbitol, Glycerin, Butylene Glycol, Cetyl Dimethicone, Aloe
Barbadensis Leaf Juice, Betula Alba (White Birch) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,
Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5,
Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl
Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate,
Ubiquinone, Jojoba Bean Meal, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic
Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Iron Oxides.

Other information
protect this product from excessive heat and direct sun

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

PRINCIPAL DISPLAY PANEL

1.7oz IO

1.7oz TD

8oz IO

3g IO

INGREDIENTS AND APPEARANCE

TINTED MOISTURIZER BROAD-SPECTRUM SPF 45  
octinoxate, octisalate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10477-7749
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
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10477-7749-1	1 in 1 CARTON	07/09/2013
1		48 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10477-7749-2	227 g in 1 TUBE; Type 0: Not a Combination Product	07/09/2013
3	NDC: 10477-7749-3	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 not final	part352	07/09/2013

Labeler - Goodier Cosmetics LLC (007317209)

Registrant - Goodier Cosmetics LP (007317209)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LP		007317209	manufacture(10477-7749)