Pura Vida Sunscreen
FDA Label NDC 59555-106

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by R & R Lotion, Inc for the product Pura Vida Sunscreen (NDC 59555-106). 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, 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

Other

Drug Facts

Otc - Purpose

Active IngredientsPurpose
Octinoxate 5.9%Sunscreen
Octisalate 3.8%Sunscreen
Oxybenzone 4.7%Sunscreen
Zinc Oxide 6.4%Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer & 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 a 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

  • apply liberally 15 minutes before sun exposure reapply:
    • after 80 minutes of swimming or sweating
    • immediatly after towel drying
    • every 2 hours

      • 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 10am-2pm
        • wear long-sleeve shirts, pants, hats, and sunglasses
          • children under 6 months: Ask a doctor

Inactive Ingredients

Purified DI Water, Octyl Stearate/Octyl Palmitate/Dioctyl Adipate, Propylene Glycol, Glyceryl Stearate & Peg 100, Cetearyl Alcohol & Ceteareth 20, Xanthan Gum, Imidazolidinyl Urea, Methyl Paraben, Propyl Paraben, Crodafos N3N, and Vitamin E.

Other Information

  • protect this product from excessive heat and direct sun

Questions Or Comments?

1-888-860-7424

Principal Display Panel - 236 Ml Bottle Label

for the
Life
of
Your Skin

Pura
Vida

Sunscreen
SPF 30+
protector solar

Zinc Oxide

BROAD SPECTRUM
80 MINUTE WATER RESISTANCE

8 FL. OZ. (236ML) e

Principal Display Panel (236 ML Bottle Label)

Principal Display Panel (236 ML Bottle Label)

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