All Calm™ Clinical Redness Corrector Spf 50

All Calm™ Clinical Redness Corrector Spf 50
SPL v5
SPL
SPL Set ID 68b95e94-3686-4d11-9952-ec86394376ee
Route
TOPICAL
Published
Effective Date 2024-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (116 mg) Zinc Cation (86 mg)
Inactive Ingredients
Cyclomethicone 5 Medium-chain Triglycerides Water Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Niacinamide Disteardimonium Hectorite Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Ferric Oxide Yellow Propylene Carbonate Disodium Lauriminodipropionate Tocopheryl Phosphates Chromic Oxide Aluminum Oxide Silicon Dioxide Dimethiconol (100000 Cst) Cyclomethicone 4 Jojoba Oil Polyhydroxystearic Acid Stearate Glyceryl Behenate/eicosadioate Levomenol Ferric Oxide Red Phenoxyethanol Crithmum Maritimum Whole Triethoxycaprylylsilane Ethylhexylglycerin Tocopherol Magnolia Officinalis Bark Benzoic Acid Ginger Dehydroacetic Acid Glycolic Acid Chloroacetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-02

Description

Drug Facts


Medication Information

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 55105-1
Active ingredients Purpose
Titanium Dioxide 11.6% Sunscreen
Zinc Oxide 8.6% Sunscreen
Warnings

For external use only.

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.
Other Information
  • Protect this product from excessive heat and direct sun.
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).

Questions Or Comments?

Call toll free 866.426.5673

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


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 55105-1 (55105-1)
Active ingredients Purpose
Titanium Dioxide 11.6% Sunscreen
Zinc Oxide 8.6% Sunscreen
Warnings

For external use only.

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.
Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients (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).

Questions Or Comments? (Questions or comments?)

Call toll free 866.426.5673

Principal Display Panel 30 Ml Tube Carton (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


Advanced Ingredient Data


Raw Label Data

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