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

Bronzing Perfector SPF 20 Sunscreen by

Drug Labeling and Warnings

Bronzing Perfector SPF 20 Sunscreen 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 6.8%	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, Ethylhexyl Hydroxystearate Benzoate, Dimethicone Crosspolymer, Glycerin, Water, Mica, Dimethicone/Vinyl Dimethicone Crosspolymer, 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, Citrus Paradisi (Grapefruit) Seed Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Reticulata (Tangerine) Peel Oil, Melissa Officinalis Leaf Powder, Ascorbic Acid, Stearic Acid, Dimethiconol, Cyclohexasiloxane, Triethoxycaprylylsilane, Calcium Silicate, Sodium Sulfate, Sodium Benzoate, Phenoxyethanol, Aluminum Hydroxide, 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

SPL UNCLASSIFIED SECTION

Distributed in USA by
Colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

colorescience®

BRONZING
PERFECTOR

3-IN-1 FACE PRIMER

Offers radiant bronze glow

Evens skin tone & texture

Water resistant
(40 minutes)

20
Broad Spectrum
SPF 20
Sunscreen

1 fl. oz. / 30 mL

INGREDIENTS AND APPEARANCE

BRONZING PERFECTOR SPF 20 SUNSCREEN 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-016
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	68 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Ethylhexyl Hydroxystearate Benzoate (UNII: 3W8F25684B)
Dimethicone Crosspolymer (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Mica (UNII: V8A1AW0880)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Dimethicone (UNII: 92RU3N3Y1O)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Rice Bran (UNII: R60QEP13IC)
Oat (UNII: Z6J799EAJK)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Dulse (UNII: 7832HOY4ZQ)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Polysaccharide-K (UNII: 3X48A86C8K)
Citrus Paradisi Seed (UNII: 12F08874Y7)
Jojoba Oil (UNII: 724GKU717M)
Tea Tree Oil (UNII: VIF565UC2G)
Lavender Oil (UNII: ZBP1YXW0H8)
CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)
Melissa Officinalis Leaf (UNII: 50D2ZE9219)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Stearic Acid (UNII: 4ELV7Z65AP)
Dimethiconol (100000 CST) (UNII: OSA9UP217S)
Cyclomethicone 6 (UNII: XHK3U310BA)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Calcium Silicate (UNII: S4255P4G5M)
Sodium Sulfate (UNII: 0YPR65R21J)
Sodium Benzoate (UNII: OJ245FE5EU)
Phenoxyethanol (UNII: HIE492ZZ3T)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Limonene, (+)- (UNII: GFD7C86Q1W)
Bismuth Oxychloride (UNII: 4ZR792I587)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-016-17	1 in 1 CARTON	02/01/2017
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68078-016-02	1 mL in 1 PACKET; Type 0: Not a Combination Product	02/01/2017

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)