Studio Fix Fluid Broad Spectrum Spf 15 With Enriched Anti-oxidant Complex
FDA Label NDC 40046-0073

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Makeup Art Cosmetics for the product Studio Fix Fluid Broad Spectrum Spf 15 With Enriched Anti-oxidant Complex (NDC 40046-0073). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, use, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7,
LONDON W1K 3BQ / MMJC

Otc - Purpose

Active IngredientsPurpose
Octinoxate 2.50%Sunscreen
Titanium Dioxide 1.00%Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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

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

Inactive Ingredients

water/aqua/eau, cyclopentasiloxane, dimethicone, peg-10 dimethicone, butylene glycol, trimethylsiloxysilicate, magnesium sulfate, dimethicone/peg-10/15 crosspolymer, tocopheryl acetate, sodium hyaluronate, algae extract, olea europaea (olive) leaf extract, oryza sativa (rice) bran extract, laminaria saccharina extract, polygonum cuspidatum root extract, lecithin, hydrogenated lecithin, methoxy amodimethicone/silsesquioxane copolymer, silica, peg/ppg-18/18 dimethicone, dimethicone crosspolymer, laureth-7, triethoxycaprylylsilane, xanthan gum, sorbitan sesquioleate, dipropylene glycol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, chloroxylenol, sorbic acid [+/- titanium dioxide (ci 77891), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499), chromium oxide greens (ci 77288)] <iln41302>

Other Information

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

Principal Display Panel - 30 Ml Tube Carton

M•A•C

STUDIO FIX FLUID
SPF 15
WITH ENRICHED
ANTI-OXIDANT COMPLEX
BROAD SPECTRUM SPF 15

30 ML/1.0 US FL OZ e

Principal Display Panel (30 mL Tube Carton)

Principal Display Panel (30 mL Tube Carton)

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