Skin Balancing Face Primer SPF 20 Sunscreen

Drug Labeling and Warnings

Drug Details [pdf]

SKIN BALANCING 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 Balancing Face Primer SPF 20 Sunscreen

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 2.1%Sunscreen
Zinc Oxide 4.1%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, Water/Aqua/Eau, Dimethicone/Vinyl Dimethicone Crosspolymer, Lactobacillus/Cocoa Fruit Ferment Filtrate, Dimethiconol, Theobroma Cacao (Cocoa) Extract, Avena Sativa (Oat) Kernel Protein, Tocopheryl Acetate, Citrus Paradisi (Grapefruit) Seed Extract, Aloe Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Rice Protein, Spirulina Maxima Extract, Melissa Officinalis (Balm Mint) Leaf Extract, Palmaria Palmata Extract, Camellia Sinensis Leaf Extract, Tocopherol, Avena Sativa (Oat) Beta Glucan, Avena Sativa (Oat) Kernel Extract, Dimethicone, Hydrogenated Soybean Oil, Stearic Acid, Caprylic/Capric Triglyceride, Cyclohexasiloxane, Triethoxycaprylylsilane, Cyclotetrasiloxane, Butylene Glycol, Propylene Glycol, Ascorbic Acid, Menthol, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Cupressus Sempervirens Oil, Cymbopogon Schoenanthus Oil, Citrus Reticulata (Tangerine) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Salvia Sclarea Oil, Fusanus Spicatus Wood Oil, Glucose, BHT, Tyrosine, Propyl Gallate, EDTA, Phenoxyethanol, Chlorphenesin, Benzyl Alcohol, Benzoic Acid, Sorbic Acid, Sodium Benzoate, Potassium Sorbate, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, Flavor/Aroma, Mica, Aluminum Hydroxide, Beta-Carotene (CI 40800), 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

Manufactured by Colorescience®
Carlsbad, CA 92008

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

colorescience®

face primer

skin balancing

Broad Spectrum SPF 20
sunscreen

1 fl oz / 30 ml

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
SKIN BALANCING FACE PRIMER SPF 20 SUNSCREEN 
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68078-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide21 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide41 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)  
Cyclomethicone 4 (UNII: CZ227117JE)  
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)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)  
Hydrogenated Soybean Oil (UNII: A2M91M918C)  
Tea Tree Oil (UNII: VIF565UC2G)  
Lavender Oil (UNII: ZBP1YXW0H8)  
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)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Citrus Aurantium Flower Oil (UNII: D4BGE91OXH)  
Citrus Paradisi Seed (UNII: 12F08874Y7)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Clary Sage Oil (UNII: 87L0D4U3M0)  
Ascorbic Acid (UNII: PQ6CK8PD0R)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Chlorphenesin (UNII: I670DAL4SZ)  
Cocoa (UNII: D9108TZ9KG)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Methylparaben (UNII: A2I8C7HI9T)  
Cupressus Sempervirens Whole (UNII: V0IW9P606J)  
Edetic Acid (UNII: 9G34HU7RV0)  
Ethylparaben (UNII: 14255EXE39)  
Butylparaben (UNII: 3QPI1U3FV8)  
Propylparaben (UNII: Z8IX2SC1OH)  
Isobutylparaben (UNII: 0QQJ25X58G)  
Menthol, Unspecified Form (UNII: L7T10EIP3A)  
Santalum Spicatum Oil (UNII: H9LVS6REV4)  
Tocopherol (UNII: R0ZB2556P8)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Peppermint Oil (UNII: AV092KU4JH)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Sorbic Acid (UNII: X045WJ989B)  
BETA CAROTENE (UNII: 01YAE03M7J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68078-009-101 in 1 CARTON10/05/201504/14/2017
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 FINALpart35210/05/201504/14/2017
Labeler - Colorescience (128731929)

Revised: 6/2019
 

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