Label: TINTED MOISTURIZER MATTE BROAD SPECTRUM SPF 45- octinoxate, octisalate, titanium dioxide, zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 10477-7603-1, 10477-7603-2, 10477-7603-3 - Packager: Goodier Cosmetics LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
1.7oz Revision Intellishade® Matte
Intellishade®
Matteanti-aging
tinted moisturizer
with sunscreenBroad-Spectrum
SPF 45NET WT 1.7 OZ | 48 g
Active ingredient ........ Purpose
Octinoxate 5.5% ........... Sunscreen
Octisalate 3.5% ............. Sunscreen
Titanium Dioxide 4% ...... Sunscreen
Zinc Oxide 3% .............. SunscreenUses
• 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 sunDirections
• 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 doctorInactive ingredients
Water (Aqua), Cyclopentasiloxane, Caprylic/Capric Triglyceride, Cetearyl Olivate, Sorbitol, Glycerin, Sorbitan
Olivate, Butylene Glycol, 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 (White Birch) Bark Extract, Camellia Sinensis
(Green Tea) Leaf Extract, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Silica, Lecithin,
Cetyl Alcohol, PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyltaurate Copolymer,
Polysorbate 60, Palmitoyl Tripeptide-5, Epigallocatechin Gallate, Ubiquinone, Jojoba Bean Meal, Glyceryl Isostearate,
Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Tocopheryl Acetate, Polyhydroxystearic Acid,
Boron Nitride, Phenoxyethanol, Chlorphenesin, Hydroxyethylcellulose, Xanthan Gum, Magnesium Chloride,
Triethoxycaprylylsilane, Sorbic Acid, Benzoic Acid, Iron Oxides. -
8oz Revision Intellishade® Matte
PROFESSIONAL
Intellishade®
Matteanti-aging
tinted moisturizer
with sunscreenBroad-Spectrum
SPF 45NET WT 8 OZ | 227 g
Active ingredient ........ Purpose
Octinoxate 5.5% ........... Sunscreen
Octisalate 3.5% ............. Sunscreen
Titanium Dioxide 4% ...... Sunscreen
Zinc Oxide 3% .............. SunscreenUses
• 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 sunDirections
• 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 doctorInactive ingredients
Water (Aqua), Cyclopentasiloxane, Caprylic/Capric Triglyceride, Cetearyl Olivate, Sorbitol, Glycerin, Sorbitan
Olivate, Butylene Glycol, 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 (White Birch) Bark Extract, Camellia Sinensis
(Green Tea) Leaf Extract, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Silica, Lecithin,
Cetyl Alcohol, PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyltaurate Copolymer,
Polysorbate 60, Palmitoyl Tripeptide-5, Epigallocatechin Gallate, Ubiquinone, Jojoba Bean Meal, Glyceryl Isostearate,
Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Tocopheryl Acetate, Polyhydroxystearic Acid,
Boron Nitride, Phenoxyethanol, Chlorphenesin, Hydroxyethylcellulose, Xanthan Gum, Magnesium Chloride,
Triethoxycaprylylsilane, Sorbic Acid, Benzoic Acid, Iron Oxides. - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TINTED MOISTURIZER MATTE BROAD SPECTRUM SPF 45
octinoxate, octisalate, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10477-7603 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:10477-7603-1 1 in 1 CARTON 06/22/2013 1 48 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10477-7603-2 227 g in 1 TUBE; Type 0: Not a Combination Product 06/22/2013 3 NDC:10477-7603-3 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 not final part352 06/22/2013 Labeler - Goodier Cosmetics LLC (007317209) Registrant - Goodier Cosmetics LLC (007317209) Establishment Name Address ID/FEI Business Operations Goodier Cosmetics LLC 007317209 manufacture(10477-7603)
