Skin Calming Face Primer SPF 20 Sunscreen

Drug Labeling and Warnings

Drug Details [pdf]

SKIN CALMING FACE PRIMER SPF 20 SUNSCREEN- 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.

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Skin Calming Face Primer SPF 20 Sunscreen

Drug Facts

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 at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: 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/Aqua/Eau, 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, Butylene Glycol, Dimethicone, Triethoxycaprylylsilane, Cyclotetrasiloxane, BHT, Propyl Gallate, Tyrosine, Glucose, Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Beta-Carotene (CI 40800), 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

Manufactured by Colorescience®
Carlsbad, CA 92008

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

colorescience®

face primer

skin calming

Broad Spectrum SPF 20
sunscreen

1 fl oz / 30 ml

SKIN CALMING FACE PRIMER SPF 20 SUNSCREEN 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-007
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/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Cyclomethicone 4 (UNII: CZ227117JE)
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Cucumber (UNII: YY7C30VXJT)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
Opuntia Ficus-Indica Stem (UNII: MUD8892KHL)
Butylene Glycol (UNII: 3XUS85K0RA)
Citrus Paradisi Seed (UNII: 12F08874Y7)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Dehydroacetic Acid (UNII: 2KAG279R6R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Dulse (UNII: 7832HOY4ZQ)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Propyl Gallate (UNII: 8D4SNN7V92)
Tyrosine (UNII: 42HK56048U)
Dextrose, unspecified form (UNII: IY9XDZ35W2)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Benzoic Acid (UNII: 8SKN0B0MIM)
BETA CAROTENE (UNII: 01YAE03M7J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-007-08	1 in 1 CARTON	10/05/2015	03/31/2017
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	10/05/2015	03/31/2017

Labeler - Colorescience (128731929)

Revised: 6/2019

Document Id: 1b9fb4f1-a585-4ad1-9fd9-c82f7629c804

34390-5

Set id: 49c82c3a-eaa3-46ec-870a-0b8f5492b1f2

Version: 2

Effective Time: 20190627