CALMING PRIMER SPF 20- titanium dioxide and zinc oxide liquid

Calming Primer SPF 20 by

Drug Labeling and Warnings

Calming 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 5.4%	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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

colorescience®

CALMING
PRIMER

3-IN-1 FACE PRIMER

Neutralizes redness

Soothes & nourishes skin

Extends makeup wear

20
Broad Spectrum
SPF 20 Sunscreen

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

1 fl. oz. / 30 mL

INGREDIENTS AND APPEARANCE

CALMING PRIMER SPF 20 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-040
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)
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)
Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M)
Dimethiconol (100000 CST) (UNII: OSA9UP217S)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
Citrus Paradisi Seed (UNII: 12F08874Y7)
Phenoxyethanol (UNII: HIE492ZZ3T)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Green Tea Leaf (UNII: W2ZU1RY8B0)
PALMARIA PALMATA (UNII: 7832HOY4ZQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Opuntia Ficus-Indica Stem (UNII: MUD8892KHL)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Benzoic Acid (UNII: 8SKN0B0MIM)
Dehydroacetic Acid (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-040-01	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)