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

Warnings

For external use only.

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.
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).

Description

Drug Facts

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
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

Warnings

For external use only.

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.
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).

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
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

All Sections (JSON)