ALL CALM CLINICAL REDNESS CORRECTOR SPF 50- titanium dioxide and zinc oxide liquid

All Calm Clinical Redness Corrector SPF 50 by

Drug Labeling and Warnings

All Calm Clinical Redness Corrector SPF 50 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 11.6%	Sunscreen
Zinc Oxide 8.6%	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: 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, Water/Aqua/Eau, Dimethicone Crosspolymer, Niacinamide, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Carbonate, Disodium Lauriminodipropionate Tocopheryl Phosphates, Crithmum Maritimum Extract, Magnolia Officinalis Bark Extract, Zingiber Officinale (Ginger) Root Extract, Magnesium Carboxymethyl Beta-Glucan, Jojoba Esters, Bisabolol, Silica, Polyhydroxystearic Acid, Dimethiconol, Alumina, Glyceryl Behenate/Eicosadioate, Phenoxyethanol, Triethoxycaprylylsilane, Ethylhexylglycerin, Tocopherol, Dehydroacetic Acid, Benzoic Acid, Glycolic Acid, Chloroacetic Acid, Chromium Oxide Greens (CI 77288), 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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Dist. in USA by
colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

colorescience®

ALL CALM™

CLINICAL REDNESS
CORRECTOR

Instantly neutralizes redness
Soothes sensitive skin

50
Broad Spectrum
SPF 50 Sunscreen
PA++++

1 fl. oz. / 30 mL

INGREDIENTS AND APPEARANCE

ALL CALM CLINICAL REDNESS CORRECTOR SPF 50 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	116 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	86 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
Niacinamide (UNII: 25X51I8RD4)
Disteardimonium Hectorite (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
Propylene Carbonate (UNII: 8D08K3S51E)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
CHROMIC OXIDE (UNII: X5Z09SU859)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
JOJOBA OIL (UNII: 724GKU717M)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
Glyceryl Behenate/Eicosadioate (UNII: 73CJJ317SR)
LEVOMENOL (UNII: 24WE03BX2T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Phenoxyethanol (UNII: HIE492ZZ3T)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
Triethoxycaprylylsilane (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
Tocopherol (UNII: R0ZB2556P8)
MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)
Benzoic Acid (UNII: 8SKN0B0MIM)
GINGER (UNII: C5529G5JPQ)
Dehydroacetic Acid (UNII: 2KAG279R6R)
Glycolic Acid (UNII: 0WT12SX38S)
Chloroacetic Acid (UNII: 5GD84Y125G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-023-24	1 in 1 CARTON	08/02/2017
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68078-023-02	1 mL in 1 PACKET; Type 0: Not a Combination Product	08/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/02/2017

Labeler - Colorescience (128731929)