Skin Brightening Face Primer SPF 20 Sunscreen

Drug Labeling and Warnings

Drug Details [pdf]

SKIN BRIGHTENING 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.

----------

Skin Brightening Face Primer SPF 20 Sunscreen

Drug Facts

Active ingredients	Purpose
Titanium Dioxide 2.5%	Sunscreen
Zinc Oxide 3.9%	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/Aqua/Eau, Cyclotetrasiloxane, Dimethiconol, Tocopherol Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Dimethicone, Stearic Acid, Citrus Paradisi (Grapefruit) Seed Extract, Butylene Glycol, Cyclohexasiloxane, Spirulina Maxima Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Reticulata (Tangerine) Leaf Oil, Avena Sativa (Oat) Kernel Protein, Melissa Officinalis Leaf Powder, Aloe Barbadensis Leaf Extract, Glycine Soja (Soybean) Oil, Palmeria Palmata Extract, Camellia Sinensis Leaf Extract, Beta-Glucan, Avena Sativa (Oat) Kernel Extract, Triethoxycaprylylsilane, Ascorbic Acid, Aluminum Hydroxide, Propyl Gallate, Tyrosine, Glucose, BHT, Phenoxyethanol, Limonene, Linalool, Beta Carotene (CI 40800)

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 brightening

Broad Spectrum SPF 20
sunscreen

1 fl oz / 30 ml

SKIN BRIGHTENING FACE PRIMER SPF 20 SUNSCREEN 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	25 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	39 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
Citrus Paradisi Seed (UNII: 12F08874Y7)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Cyclomethicone 6 (UNII: XHK3U310BA)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
Ascorbic Acid (UNII: PQ6CK8PD0R)
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)
Soybean Oil (UNII: 241ATL177A)
Dulse (UNII: 7832HOY4ZQ)
Green Tea Leaf (UNII: W2ZU1RY8B0)
BETA CAROTENE (UNII: 01YAE03M7J)
Propyl Gallate (UNII: 8D4SNN7V92)
Tyrosine (UNII: 42HK56048U)
Dextrose, unspecified form (UNII: IY9XDZ35W2)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-005-06	1 in 1 CARTON	10/05/2015	06/11/2017
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/05/2015	06/11/2017

Labeler - Colorescience (128731929)

Revised: 6/2019

Document Id: 315fe80d-c693-4ce4-a2c5-f8750ece2cfe

34390-5

Set id: 71a81955-0f76-4481-beac-cdff5e512e4a

Version: 2

Effective Time: 20190627