TINTED SPF 45 - octinoxate, octisalate, zinc oxide cream 
Goodier Cosmetics, LP

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.

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Revision Skincare 1.7oz Retail Intellishade®

    Intellishade®
    SPF 45 Original

     anti-aging
     tinted moisturizer
     for all skin types


     NT WT 1.7 OZ / 48 G

    Active Ingredient   Purpose

     Octinoxate 7.5%        Sunscreen
     Octisalate 5%            Sunscreen
     Zinc Oxide 2%           Sunscreen

    Uses
  • helps prevent sunburn
  • higher SPF gives more sun protection
  • for skin highly sensitive to sunburn

    Warnings

    for external use only

    When using this product

  • keep out of eyes, rinse with water to remove.

    Stop use and ask a doctor if
  • rash or irritation develops and lasts.

    Keep this and all drugs out of reach
    of children.
  If swallowed, get medical
    help or contact a Poison Control
    Center right away.

    Directions
  • apply evenly before sun exposure and as needed.

    Other Information
    High sun protection product

   Inactive ingredients
    Water (Aqua), Cyclopentasiloxane, Ethylhexyl Stearate, Sorbitol,
    Caprylic/Capric Triglyceride, Glycerin, Polyglyceryl-4 Isostearate,
    Cetyl PEG/PPG 10/1 Dimethicone, Hexyl Laurate, Aloe Barbadensis
    Leaf Juice, Cetyl Dimethicone, Betula Alba (White Birch) Extract,
    Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,
    Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl
    Ascorbate, Hydrogenated Castor Oil, Lecithin, Butylene Glycol, Caprylyl
    Glycol, Palmitoyl Tripeptide-5, Saccharomyces Cerevisiae Extract,
    Ubiquinone, Retinyl Palmitate, Sodium Chloride, Phenoxyethanol,
    Chlorphenesin, Triethoxycaprylylsilane, Benzoic Acid, Sorbic Acid,
    Titanium Dioxide, Iron Oxides


    Dist. by Revision, Inc.
    Dallas, TX 75247 Made in U.S.A.

Revercel 1.7oz Retail Triple Duty Sunscreen

    triple duty
    sunscreen


    spf 45
    sheer tint


    net. wt. 1.7oz / 48g

     Active Ingredient   Purpose

     Octinoxate 7.50%        Sunscreen
     Octisalate 5.00%         Sunscreen
     Zinc Oxide 2.00%        Sunscreen

    Uses

  • Helps prevent sunburn.
  • Higher SPF gives more sun protection.
  • For skin highly sensitive to sunburn.

    Warnings

    For external use only.

    When using this product

  • Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

  • Rash or irritation develops and lasts.

    Keep out of reach of children.
    If swallowed, get medical help or contact a
    Poison Control Center right away.

    Directions

  • Apply evenly before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply as needed or after towel drying, swimming or perspiring.

    Other Information
    High sun protection product.

   Inactive ingredients
    Water (Aqua), Cyclopentasiloxane, Ethylhexyl Stearate, Sorbitol,
    Caprylic/Capric Triglyceride, Glycerin, Polyglyceryl-4 Isostearate,
    Cetyl PEG/PPG 10/1 Dimethicone, Hexyl Laurate, Aloe Barbadensis
    Leaf Juice, Cetyl Dimethicone, Betula Alba (White Birch) Extract,
    Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,
    Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl
    Ascorbate, Hydrogenated Castor Oil, Lecithin, Butylene Glycol, Caprylyl
    Glycol, Palmitoyl Tripeptide-5, Saccharomyces Cerevisiae Extract,
    Ubiquinone, Retinyl Palmitate, Sodium Chloride, Phenoxyethanol,
    Chlorphenesin, Triethoxycaprylylsilane, Benzoic Acid, Sorbic Acid,
    Titanium Dioxide, Iron Oxides

Made in the USA

Distributed by Revercel, LLC
Cambell, CA 95008

Revision Skincare 8oz Professional Intellishade®

Intellishade®
SPF 45 Original

tinted moisturizer
for all skin types


NT WT 8 OZ / 227 G

     Skin Type:

    Suitable for all skin types to even out skin tone
    and protect against sunburn after procedures
    such as laser therapy, microdermabrasion and
    chemical peels.

    Active Ingredients:

    Octinoxate 7.5%, Octisalate 5.0%, Zinc Oxide 2.0%

    Key Ingredients and Benefits:

  • Broad spectrum sunscreens protect against UVA and UVB damage
  • Coenzyme Q10 and standardized Green Tea Extract provide antioxidant benefits
  • Natural minerals even out skin tone and conceal redness
  • THD Ascorbate (Vitamin C) and Palmitoyl Tripeptide-5 help reduce the appearance of fine lines and wrinkles

   

    Directions:

     Apply liberally to face and neck to help protect skin and conceal redness.


    Professional size only. Not for resale.

    Dist. by Revision, Inc
    Dallas, TX 75247 Made in U.S.A.


Intellishade® SPF 45 1.7oz Carton Image

Triple Duty SPF 45 1.7oz Carton Image

Intellishade® SPF 45 8oz Carton Image

Intellishade® SPF 45 0.12oz Carton Image

TINTED SPF 45 
octinoxate, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10477-2627
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
SORBITOL (UNII: 506T60A25R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
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, D- (UNII: A7E6112E4N)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
UBIDECARENONE (UNII: EJ27X76M46)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBIC ACID (UNII: X045WJ989B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10477-2627-11 in 1 CARTON
148 g in 1 TUBE
2NDC:10477-2627-2227 g in 1 TUBE
3NDC:10477-2627-33 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2007
Labeler - Goodier Cosmetics, LP (007317209)
Registrant - Goodier Cosmetics, LP (007317209)
Establishment
NameAddressID/FEIBusiness Operations
Goodier Cosmetics, LP007317209manufacture

Revised: 12/2011
Document Id: cfc06532-2c88-4de7-9c63-2cbba8f59817
Set id: 6b68c45a-8685-4166-8628-2d304048251c
Version: 1
Effective Time: 20111205
 
Goodier Cosmetics, LP