BRIGHTENING PERFECTOR SPF 20 SUNSCREEN- titanium dioxide and zinc oxide liquid

Brightening Perfector SPF 20 Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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:
  • 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, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Water, Dimethiconol, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Dimethicone, Stearic Acid, Citrus Paradisi (Grapefruit) Seed Extract, Cyclohexasiloxane, Spirulina Maxima Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Reticulata (Tangerine) Peel 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, 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

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Distributed in USA by
Colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

colorescience®

BRIGHTENING
PERFECTOR

3-IN-1 FACE PRIMER

Illuminates skin tone

Revives dull looking skin

Water resistant
(40 minutes)

20
Broad Spectrum
SPF 20
Sunscreen

1 fl. oz. / 30 mL

INGREDIENTS AND APPEARANCE

BRIGHTENING PERFECTOR SPF 20 SUNSCREEN 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-015
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)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
Ethylhexyl Hydroxystearate Benzoate (UNII: 3W8F25684B)
Glycerin (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
Water (UNII: 059QF0KO0R)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
Dimethicone (UNII: 92RU3N3Y1O)
Stearic Acid (UNII: 4ELV7Z65AP)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
Cyclomethicone 6 (UNII: XHK3U310BA)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
TEA TREE OIL (UNII: VIF565UC2G)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)
OAT (UNII: Z6J799EAJK)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SOYBEAN OIL (UNII: 241ATL177A)
DULSE (UNII: 7832HOY4ZQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYSACCHARIDE-K (UNII: 3X48A86C8K)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Limonene, (+)- (UNII: GFD7C86Q1W)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-015-16	1 in 1 CARTON	02/01/2017
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	02/01/2017

Labeler - Colorescience (128731929)