Pro Triple Protection Factor Face And Body Broad Spectrum Spf 30 Sunscreen
FDA Label NDC 67938-2076

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 Face And Body Broad Spectrum Spf 30 Sunscreen (NDC 67938-2076). 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

OCTINOXATE 7.5 % W/W

OXYBENZONE 5.0 % W/W

OCTISALATE 5.0 % W/W

OCTOCRYLENE 5.0 % W/W

AVOBENZONE 3.0 % W/W

Purpose

Sunscreen

Sunscreen

Sunscreen

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, NYLON-12, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, DIMETHICONE, PENTYLENE GLYCOL, CETEARYL ALCOHOL, CAPRYLYL METHICONE, ACETYL FARNESYLCYSTEINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ARABIDOPSIS THALIANA EXTRACT, CAPRYLYL GLYCOL, CARNOSINE, CETETH-20 PHOSPHATE, CHONDRUS CRISPUS EXTRACT, COCO-GLUCOSIDE, DICETYL PHOSPHATE, DISODIUM EDTA, ERGOTHIONEINE, HYDROXYACETOPHENONE, LECITHIN, MICROCOCCUS LYSATE, PLANKTON EXTRACT, SODIUM HYALURONATE, SODIUM PCA, TOCOPHERYL ACETATE, BHT, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM DEHYDROACETATE.

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
FACE & BODY

Broad Spectrum
SPF 30 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

4 FL. OZ. (120 ml)

Principal Display Panel (Bottle Label)

Principal Display Panel (Bottle Label)

Principal Display Panel - Carton Label

ElizabethArden

PRO

TRIPLE
PROTECTION
FACTOR
FACE & BODY

Broad Spectrum
SPF 30 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

4 FL. OZ. (120 ml)

Principal Display Panel (Carton Label)

Principal Display Panel (Carton Label)

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