Skin Mattifying Face Primer SPF 20 Sunscreen

Drug Labeling and Warnings

Drug Details [pdf]

SKIN MATTIFYING FACE PRIMER SPF 20 SUNSCREEN- titanium dioxide and zinc oxide liquid 
Colorescience

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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Skin Mattifying Face Primer SPF 20 Sunscreen

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 2.8%Sunscreen
Zinc Oxide 5.3%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. Works best on moisturized skin.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor.
  • 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.

Inactive ingredients

Cyclopentasiloxane, Dimethicone Crosspolymer, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Water, Salicylic Acid, Dimethicone, Tocopheryl Acetate, Hydrolyzed Rice Protein, Avena Sativa (Oat) Kernel Protein, Spirulina Maxima Extract, Aloe Barbadensis Leaf Extract, Palmaria Palmata Extract, Camellia Sinensis Leaf Extract, Beta-Glucan, Avena Sativa (Oat) Kernel Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Melissa Officinalis Leaf Powder, Stearic Acid, Dimethiconol, Butylene Glycol, Cyclohexasiloxane, Triethoxycaprylylsilane, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Reticulata (Tangerine) Peel Oil, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Cananga Odorata Flower Oil, Cymbopogon Schoenanthus Oil, Salvia Sclarea (Clary) Oil, Cupressus Sempervirens Oil, BHT, Propyl Gallate, Tyrosine, Glucose, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, Mica, Aluminum Hydroxide, Citral, Farnesol, Geraniol, Limonene, Linalool, Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491, CI 77492, CI 77499)

Other information

  • Protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 866.426.5673

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

colorescience®

face primer

skin mattifying

Broad Spectrum SPF 20
sunscreen

1 fl oz / 30 ml

Principal Display Panel - 30 ml Tube Carton
SKIN MATTIFYING FACE PRIMER SPF 20 SUNSCREEN 
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68078-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide28 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide53 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Ethylhexyl Hydroxystearate Benzoate (UNII: 3W8F25684B)  
Dimethicone/Vinyl Dimethicone Crosspolymer (soft particle) (UNII: 9E4CO0W6C5)  
Water (UNII: 059QF0KO0R)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Jojoba Oil (UNII: 724GKU717M)  
Glycerin (UNII: PDC6A3C0OX)  
Dimethicone (UNII: 92RU3N3Y1O)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Salicylic Acid (UNII: O414PZ4LPZ)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Tea Tree Oil (UNII: VIF565UC2G)  
Lavender Oil (UNII: ZBP1YXW0H8)  
Linalool, (+/-)- (UNII: D81QY6I88E)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Citrus Reticulata Leaf Oil (UNII: 1515UE78IH)  
Oat (UNII: Z6J799EAJK)  
Melissa Officinalis Leaf (UNII: 50D2ZE9219)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Mica (UNII: V8A1AW0880)  
Dulse (UNII: 7832HOY4ZQ)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Bismuth Oxychloride (UNII: 4ZR792I587)  
Propyl Gallate (UNII: 8D4SNN7V92)  
Tyrosine (UNII: 42HK56048U)  
Dextrose, Unspecified Form (UNII: IY9XDZ35W2)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Cymbopogon Schoenanthus Oil (UNII: XE7K568ILO)  
Cananga Oil (UNII: 8YOY78GNNX)  
Citrus Aurantium Flower Oil (UNII: D4BGE91OXH)  
Cupressus Sempervirens Whole (UNII: V0IW9P606J)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Clary Sage Oil (UNII: 87L0D4U3M0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68078-008-091 in 1 CARTON10/05/201502/26/2017
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/05/201502/26/2017
Labeler - Colorescience (128731929)

Revised: 6/2019
 
Colorescience