FDA Label for Pro Triple Protection Factor Broad Spectrum Spf 50 Sunscreen

View Indications, Usage & Precautions

Pro Triple Protection Factor Broad Spectrum Spf 50 Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Elizabeth Arden, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Titanium Dioxide 6.1 % W/W

Zinc Oxide 5.6 % W/W


Purpose



Sunscreen

Sunscreen


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

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:
    • At least every 2 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 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-sleeve shirts, pants, hats, and sunglasses
      • Children under 6 months: Ask a doctor.

Inactive Ingredients



WATER/AQUA/EAU, CYCLOPENTASILOXANE, ISODODECANE, C12-15 ALKYL BENZOATE, CAPRYLYL METHICONE, DIMETHICONE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PENTYLENE GLYCOL, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARDIMONIUM HECTORITE, RICINOLETH-40, ETHOXYDIGLYCOL, CARNOSINE, ACETYL FARNESYLCYSTEINE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ALLYL CAPROATE, ARABIDOPSIS THALIANA EXTRACT, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CHONDRUS CRISPUS EXTRACT, DIPROPYLENE GLYCOL, ERGOTHIONEINE, ETHYL DECADIENOATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, HYDROGEN DIMETHICONE, LECITHIN, METHYLDIHYDROJASMONATE, METHYLENEDIOXYPHENYL METHYLPROPANAL, MICROCOCCUS LYSATE, PEG/PPG-18/18 DIMETHICONE, PLANKTON EXTRACT, SILICA, SODIUM HYALURONATE, SODIUM PCA, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, IRON OXIDES (CI 77491, CI 77492, CI 77499).


Other Information



  • Protect this product from excessive heat and direct sun
  • Store at room temperature

Questions Or Comments?



Call toll free 1-844-273-3679


Principal Display Panel - Bottle Label



ElizabethArden

PRO

TRIPLE
PROTECTION
FACTOR

Broad Spectrum
SPF 50 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

PHYSICAL SUNSCREEN
UNIVERSAL TINT

RECOMMENDED

SKIN
CANCER
FOUNDATION

DAILY USE

RECOMMENDED AS
AN EFFECTIVE
BROAD SPECTRUM
SUNSCREEN

1.7 FL. OZ. (50 ml)


Principal Display Panel - Carton Label



ElizabethArden

PRO

TRIPLE
PROTECTION
FACTOR

Broad Spectrum
SPF 50 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

PHYSICAL SUNSCREEN
UNIVERSAL TINT

RECOMMENDED

SKIN
CANCER
FOUNDATION

DAILY USE

RECOMMENDED AS
AN EFFECTIVE
BROAD SPECTRUM
SUNSCREEN

1.7 FL. OZ. (50 ml)


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