TINTED SPF 45- octinoxate, octisalate, zinc oxide cream

Tinted SPF 45 by

Drug Labeling and Warnings

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

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTED SPF 45 
octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10477-2627
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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10477-2627-1	1 in 1 CARTON
1		48 g in 1 TUBE
2	NDC: 10477-2627-2	227 g in 1 TUBE
3	NDC: 10477-2627-3	3 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2007

Labeler - Goodier Cosmetics, LP (007317209)

Registrant - Goodier Cosmetics, LP (007317209)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics, LP		007317209	manufacture