BRIGHTENING PRIMER SPF 20- titanium dioxide and zinc oxide liquid

Brightening Primer SPF 20 by

Drug Labeling and Warnings

Brightening Primer SPF 20 by is a Otc medication manufactured, distributed, or labeled by Colorescience. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 5.0%	Sunscreen
Zinc Oxide 4.5%	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:
  • After 40 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.
• Children under 6 months: 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, Caprylic/Capric Triglyceride, Aqua/Water, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopherol Acetate, Mica, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Rice Protein, Dimethiconol, Avena Sativa (Oat) Kernel Protein, Spirulina Maxima Extract, Alumina, Silica, Jojoba Esters, Polyhydroxystearic Acid, Glyceryl Behenate/Eicosadioate, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Reticulata (Tangerine) Peel Oil, Palmeria Palmata Extract, Camellia Sinensis Leaf Extract, Lauroyl Lysine, Palmitoyl Tripeptide-5, Glycine Soja (Soybean) Oil, Tocopherol, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, 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 Bottle Carton

colorescience®

BRIGHTENING
PRIMER

3-IN-1 FACE PRIMER

Illuminates skin tone
Revives dull looking skin
Extends makeup wear

20
Broad Spectrum
SPF 20 Sunscreen
PA+++

CHEMICAL-FREE ACTIVES | 100% MINERAL
WATER/SWEAT RESISTANT (40 MINUTES)

1 fl. oz. / 30 mL

INGREDIENTS AND APPEARANCE

BRIGHTENING PRIMER SPF 20 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	50 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	4.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Mica (UNII: V8A1AW0880)
JOJOBA OIL (UNII: 724GKU717M)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
OAT (UNII: Z6J799EAJK)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Glyceryl Behenate/Eicosadioate (UNII: 73CJJ317SR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TEA TREE OIL (UNII: VIF565UC2G)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MANDARIN OIL (UNII: NJO720F72R)
PALMARIA PALMATA (UNII: 7832HOY4ZQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
Lauroyl Lysine (UNII: 113171Q70B)
Palmitoyl Tripeptide-5 (UNII: 2A3916MQHO)
SOYBEAN OIL (UNII: 241ATL177A)
Tocopherol (UNII: R0ZB2556P8)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)
Sodium Benzoate (UNII: OJ245FE5EU)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BETA CAROTENE (UNII: 01YAE03M7J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-037-01	1 in 1 CARTON	01/01/2020
1		30 mL in 1 BOTTLE; 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	01/01/2020

Labeler - Colorescience (128731929)