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

Calming Perfector SPF 20 Sunscreen by

Drug Labeling and Warnings

Calming 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 5.4%	Sunscreen
Zinc Oxide 5.4%	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, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Glycerin, Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Cucumis Sativus (Cucumber) Fruit Extract, Spirulina Maxima Extract, Camellia Sinensis Leaf Extract, Opuntia Ficus-Indica Stem Extract, Palmaria Palmata Extract, Disodium Lauriminodipropionate Tocopheryl Phosphates, Citrus Paradisi (Grapefruit) Seed Extract, Ascorbic Acid, Dimethiconol, Dimethicone, Triethoxycaprylylsilane, Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, 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

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Distributed in USA by
Colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

colorescience®

CALMING
PERFECTOR

3-IN-1 FACE PRIMER

Neutralizes redness

Soothes & nourishes skin

Water resistant
(40 minutes)

20
Broad Spectrum
SPF 20
Sunscreen

1 fl. oz. / 30 mL

INGREDIENTS AND APPEARANCE

CALMING PERFECTOR SPF 20 SUNSCREEN 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	54 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	54 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Dimethicone Crosspolymer (450000 MPA.S at 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Cucumber (UNII: YY7C30VXJT)
Arthrospira Maxima (UNII: 9K7IG15M0Q)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Opuntia Ficus-Indica Stem (UNII: MUD8892KHL)
Dulse (UNII: 7832HOY4ZQ)
Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M)
Citrus Paradisi Seed (UNII: 12F08874Y7)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Dimethiconol (100000 CST) (UNII: OSA9UP217S)
Dimethicone (UNII: 92RU3N3Y1O)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Benzoic Acid (UNII: 8SKN0B0MIM)
Dehydroacetic Acid (UNII: 2KAG279R6R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferrosoferric Oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-017-18	1 in 1 CARTON	02/01/2017
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68078-017-02	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)