Studio Fix Fluid Spf 15 Broad Spectrum

Studio Fix Fluid Spf 15 Broad Spectrum
SPL v10
SPL
SPL Set ID ff48435d-245a-4037-9afb-caee83c4c415
Route
TOPICAL
Published
Effective Date 2018-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (25 mg) Titanium Dioxide (10 mg)
Inactive Ingredients
Water Cyclomethicone 5 Butylene Glycol Dimethicone Magnesium Sulfate, Unspecified Form Saccharina Latissima .alpha.-tocopherol Acetate Hyaluronate Sodium Tocopherol Xanthan Gum Sorbitan Sesquioleate Laureth-7 Dipropylene Glycol Peg/ppg-18/18 Dimethicone Disteardimonium Hectorite Silicon Dioxide Triethoxycaprylylsilane Propylene Carbonate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Sorbic Acid Chloroxylenol Phenoxyethanol Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Chromic Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-12-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Use

helps prevent sunburn

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If product is 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
Octinoxate 2.50% Sunscreen
Titanium Dioxide 1.00% Sunscreen
Warnings

For external use only

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply every two hours
  • use a water resistant sunscreen if swimming or sweating
  • 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
  • children under 6 months of age: ask a doctor
Other Information

protect the product in this container from excessive heat and direct sun

Inactive Ingredients

water/aqua/eau, cyclopentasiloxane, peg-10 dimethicone, butylene glycol, trimethylsiloxysilicate, dimethicone, magnesium sulfate, laminaria saccharina extract, algae extract, tocopheryl acetate, sodium hyaluronate, tocopherol, lecithin, hydrogenated lecithin, xanthan gum, sorbitan sesquioleate, methoxy amodimethicone/silsesquioxane copolymer, laureth-7, dipropylene glycol, dimethicone/peg-10/15 crosspolymer, dimethicone/peg-10 crosspolymer, peg/ppg-18/18 dimethicone, disteardimonium hectorite, silica, dimethicone crosspolymer, triethoxycaprylylsilane, propylene carbonate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sorbic acid, chloroxylenol, phenoxyethanol [+/- titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), chromium oxide greens (ci 77288)] <iln36878>

Principal Display Panel 30 Ml Bottle Carton

M•A•C

STUDIO FIX FLUID



SPF 15



BROAD SPECTRUM SPF 15

30 ML/1.0 US FL OZ e


Structured Label Content

Use

helps prevent sunburn

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If product is 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
Octinoxate 2.50% Sunscreen
Titanium Dioxide 1.00% Sunscreen
Warnings

For external use only

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply every two hours
  • use a water resistant sunscreen if swimming or sweating
  • 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
  • children under 6 months of age: ask a doctor
Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Inactive Ingredients (inactive ingredients)

water/aqua/eau, cyclopentasiloxane, peg-10 dimethicone, butylene glycol, trimethylsiloxysilicate, dimethicone, magnesium sulfate, laminaria saccharina extract, algae extract, tocopheryl acetate, sodium hyaluronate, tocopherol, lecithin, hydrogenated lecithin, xanthan gum, sorbitan sesquioleate, methoxy amodimethicone/silsesquioxane copolymer, laureth-7, dipropylene glycol, dimethicone/peg-10/15 crosspolymer, dimethicone/peg-10 crosspolymer, peg/ppg-18/18 dimethicone, disteardimonium hectorite, silica, dimethicone crosspolymer, triethoxycaprylylsilane, propylene carbonate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sorbic acid, chloroxylenol, phenoxyethanol [+/- titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), chromium oxide greens (ci 77288)] <iln36878>

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

M•A•C

STUDIO FIX FLUID



SPF 15



BROAD SPECTRUM SPF 15

30 ML/1.0 US FL OZ e


Advanced Ingredient Data


Raw Label Data

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