Mac Studio Fix Fluid Broad Spectrum Spf 15

Mac Studio Fix Fluid Broad Spectrum Spf 15
SPL v2
SPL
SPL Set ID fb59afc1-1dc9-f783-e053-6394a90a196b
Route
TOPICAL
Published
Effective Date 2023-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (30 mg) Titanium Dioxide (10 mg)
Inactive Ingredients
High Density Polyethylene Disteardimonium Hectorite Aluminum Oxide Water Trimethylsiloxysilicate (m/q 0.6-0.8) Isododecane Saccharina Latissima Chloroxylenol Ferric Oxide Yellow Magnesium Sulfate, Unspecified Peg-10 Dimethicone (600 Cst) Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Porphyridium Purpureum Salix Nigra Bark Lecithin, Soybean Hydrogenated Soybean Lecithin Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Methyl Dihydrojasmonate (synthetic) Sorbic Acid Xanthan Gum Hyaluronate Sodium .alpha.-tocopherol Acetate Silicon Dioxide Triethoxycaprylylsilane Dimethicone/peg-10/15 Crosspolymer Sorbitan Sesquioleate Salicylic Acid Sodium Citrate Dipropylene Glycol Ferrosoferric Oxide Ferric Oxide Red Dimethicone Propylene Carbonate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Caffeine Laureth-7 Butylated Hydroxytoluene Phenoxyethanol Methyl Trimethicone Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-12

Description

Octinoxate 3.0% Titanium Dioxide 1.0%

Purpose

Sunscreen


Medication Information

Warnings and Precautions

For External use only

Purpose

Sunscreen

Description

Octinoxate 3.0% Titanium Dioxide 1.0%

Use

helps prevent sunburn

Directions
  • For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • reapply at least 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
Do Not Use

on damaged or broken skin

Other Information

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

Active Ingredients

Octinoxate 3.0%

Titanium Dioxide 1.0%

Inactive Ingredients

WATER\AQUA\EAU,METHYL TRIMETHICONE,DIMETHICONE,TRIMETHYLSILOXYSILICATE,PEG-10 DIMETHICONE,BUTYLENE GLYCOL,ISODODECANE,POLYETHYLENE,CETYL PEG/PPG-10/1 DIMETHICONE,MAGNESIUM SULFATE,ALGAE EXTRACT,LAMINARIA SACCHARINA EXTRACT,SODIUM HYALURONATE,SALIX NIGRA (WILLOW) BARK EXTRACT,TOCOPHERYL ACETATE,CAFFEINE,LECITHIN,HYDROGENATED LECITHIN,DISTEARDIMONIUM HECTORITE,SILICA,XANTHAN GUM,DIMETHICONE CROSSPOLYMER,TRIETHOXYCAPRYLYLSILANE,DIMETHICONE/PEG-10/15 CROSSPOLYMER,METHOXY AMODIMETHICONE/SILSESQUIOXANE COPOLYMER,SORBITAN SESQUIOLEATE,SALICYLIC ACID,SODIUM CITRATE,LAURETH-7,METHYLDIHYDROJASMONATE,PROPYLENE CARBONATE,ALUMINA,DIPROPYLENE GLYCOL,PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,BHT,PHENOXYETHANOL,SORBIC ACID,CHLOROXYLENOL, [+/- TITANIUM DIOXIDE (CI 77891),IRON OXIDES (CI 77491),IRON OXIDES (CI 77492),IRON OXIDES (CI 77499)] <ILN50543>

Principal Display Panel

MAC

STUDIO FIX

FLUID BROAD SPECTRUM SPF 15

24 HR MATTE FOUNDATION + OIL CONTROL

1.0 FL.OZ.LIQ/30ML e

When Using This Product

keep out of eyes, Rinse with water to remove

Stop Use and Ask A Doctor If

rash occurs

Keep Out of Reach of Children

If product is swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Use (USE)

helps prevent sunburn

Warnings and Precautions (34071-1)

For External use only

Purpose

Sunscreen

Directions
  • For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • reapply at least 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
Do Not Use (Do not use)

on damaged or broken skin

Other Information

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

Active Ingredients

Octinoxate 3.0%

Titanium Dioxide 1.0%

Inactive Ingredients

WATER\AQUA\EAU,METHYL TRIMETHICONE,DIMETHICONE,TRIMETHYLSILOXYSILICATE,PEG-10 DIMETHICONE,BUTYLENE GLYCOL,ISODODECANE,POLYETHYLENE,CETYL PEG/PPG-10/1 DIMETHICONE,MAGNESIUM SULFATE,ALGAE EXTRACT,LAMINARIA SACCHARINA EXTRACT,SODIUM HYALURONATE,SALIX NIGRA (WILLOW) BARK EXTRACT,TOCOPHERYL ACETATE,CAFFEINE,LECITHIN,HYDROGENATED LECITHIN,DISTEARDIMONIUM HECTORITE,SILICA,XANTHAN GUM,DIMETHICONE CROSSPOLYMER,TRIETHOXYCAPRYLYLSILANE,DIMETHICONE/PEG-10/15 CROSSPOLYMER,METHOXY AMODIMETHICONE/SILSESQUIOXANE COPOLYMER,SORBITAN SESQUIOLEATE,SALICYLIC ACID,SODIUM CITRATE,LAURETH-7,METHYLDIHYDROJASMONATE,PROPYLENE CARBONATE,ALUMINA,DIPROPYLENE GLYCOL,PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,BHT,PHENOXYETHANOL,SORBIC ACID,CHLOROXYLENOL, [+/- TITANIUM DIOXIDE (CI 77891),IRON OXIDES (CI 77491),IRON OXIDES (CI 77492),IRON OXIDES (CI 77499)] <ILN50543>

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MAC

STUDIO FIX

FLUID BROAD SPECTRUM SPF 15

24 HR MATTE FOUNDATION + OIL CONTROL

1.0 FL.OZ.LIQ/30ML e

When Using This Product (When using this product)

keep out of eyes, Rinse with water to remove

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

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


Advanced Ingredient Data


Raw Label Data

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