Pro Triple Protection Factor Broad Spectrum Spf 50 Sunscreen
FDA Label NDC 67938-2075

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Elizabeth Arden, Inc for the product Pro Triple Protection Factor Broad Spectrum Spf 50 Sunscreen (NDC 67938-2075). 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 active ingredients, purpose, uses, 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

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions For Sunscreen Use:

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Principal Display Panel - Bottle Label

→ Principal Display Panel - Carton Label

Active Ingredients

Titanium Dioxide 6.1 % W/W

Zinc Oxide 5.6 % W/W

Purpose

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 (Bottle Label)

Principal Display Panel - Carton Label