CALMING PRIMER SPF 20- titanium dioxide and zinc oxide liquid 
Colorescience

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Calming Primer SPF 20

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 5.4%Sunscreen
Zinc Oxide 5.4%Sunscreen

Uses

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

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

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
CALMING PRIMER SPF 20 
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide54 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide54 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68078-040-011 in 1 CARTON01/01/2020
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2020
Labeler - Colorescience (128731929)

Revised: 10/2021
Document Id: ce4f32cf-3ed6-42ff-89d8-256307ffa4b3
Set id: d681cdb5-307e-4a2a-8e1d-2b29131d48d0
Version: 1
Effective Time: 20211007
 
Colorescience