mattifying primer spf 20

mattifying primer spf 20
SPL v4
SPL
SPL Set ID b27d7df0-3c84-4cc5-9ef3-07105311fed9
Route
topical
Published
Effective Date 2023-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (50 mg) zinc oxide (4.5 mg)
Inactive Ingredients
cyclomethicone 5 dimethicone crosspolymer medium-chain triglycerides water glycerin dimethicone, unspecified .alpha.-tocopherol acetate mica jojoba oil dimethiconol (100000 cst) oat salicylic acid arthrospira maxima aluminum oxide silicon dioxide polyhydroxystearic acid (2300 mw) glyceryl behenate/eicosadioate aloe vera leaf tea tree oil lavender oil mandarin oil green tea leaf lauroyl lysine palmitoyl tripeptide-5 tocopherol phenoxyethanol ethylhexylglycerin sodium benzoate triethoxycaprylylsilane linalool, (+/-)- ferric oxide red ferric oxide yellow ferrosoferric oxide pentylene glycol geraniol linalyl acetate lavandin oil hydrolyzed rice protein (enzymatic; 2000 mw) limonene, (+)-

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-01-01

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:
    • After 40 minutes of swimming or sweating.
    • Immediately after towel drying.
    • At least every 2 hours.
  • 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, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Water, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopherol Acetate, Mica, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Rice Protein, Dimethiconol, Avena Sativa (Oat) Kernel Protein, Salicylic Acid, Spirulina Maxima Extract, Alumina, Silica, Jojoba Esters, Polyhydroxystearic Acid, Glyceryl Behenate/Eicosadioate, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Reticulata (Tangerine) Peel Oil, Palmeria Palmata Extract, Camellia Sinensis Leaf Extract, Lauroyl Lysine, Palmitoyl Tripeptide-5, Tocopherol, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, Limonene, Linalool, Iron Oxides (CI77491, CI77492, CI77499).

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 5.0% Sunscreen
Zinc Oxide 4.5% Sunscreen
Questions Or Comments?

Call toll free 866.426.5673

Principal Display Panel 30 Ml Bottle Carton

colorescience®

MATTIFYING

PRIMER

3-IN-1 FACE PRIMER

+ Helps reduce oil and shine

+ Minimizes pore appearance

+ Extends makeup wear

20

Broad Spectrum

SPF 20 Sunscreen

PA+++

ALL-MINERAL ACTIVES

WATER/SWEAT RESISTANT

(40 MINUTES)

Net Wt. 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:
    • After 40 minutes of swimming or sweating.
    • Immediately after towel drying.
    • At least every 2 hours.
  • 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, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Water, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopherol Acetate, Mica, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Rice Protein, Dimethiconol, Avena Sativa (Oat) Kernel Protein, Salicylic Acid, Spirulina Maxima Extract, Alumina, Silica, Jojoba Esters, Polyhydroxystearic Acid, Glyceryl Behenate/Eicosadioate, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Reticulata (Tangerine) Peel Oil, Palmeria Palmata Extract, Camellia Sinensis Leaf Extract, Lauroyl Lysine, Palmitoyl Tripeptide-5, Tocopherol, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, Limonene, Linalool, Iron Oxides (CI77491, CI77492, CI77499).

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 5.0% Sunscreen
Zinc Oxide 4.5% Sunscreen
Questions Or Comments? (Questions or comments?)

Call toll free 866.426.5673

Principal Display Panel 30 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton)

colorescience®

MATTIFYING

PRIMER

3-IN-1 FACE PRIMER

+ Helps reduce oil and shine

+ Minimizes pore appearance

+ Extends makeup wear

20

Broad Spectrum

SPF 20 Sunscreen

PA+++

ALL-MINERAL ACTIVES

WATER/SWEAT RESISTANT

(40 MINUTES)

Net Wt. 1 fl. oz. / 30 mL


Advanced Ingredient Data


Raw Label Data

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