Pura Vida Sunscreen

Manufacturer
R & R Lotion, Inc
Effective date
2021-01-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:30

Label at a glance#

ProductPura Vida Sunscreen
Active ingredientZinc Oxide, Octinoxate, Octisalate, Oxybenzone
Label structure9 sections

Indications and 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

Dosage and administration

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, especial...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes.

Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a doctor if a rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

1-888-860-7424

PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59555-106-032025-01-30C16284748780-12cef2736-6cb4-d83d-e063-dadaa90ab31fPura Vida Sunscreen
59555-106-082025-01-30C16284748780-12cef2736-6cb4-d83d-e063-dadaa90ab31fPura Vida Sunscreen
59555-106-112025-01-30C16284748780-12cef2736-6cb4-d83d-e063-dadaa90ab31fPura Vida Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59555-106-03Pura Vida Sunscreen50 mL in 1 BOTTLE, PUMPLOTION503
59555-106-08Pura Vida Sunscreen3785 mL in 1 BOTTLE, PUMPLOTION37853
59555-106-11Pura Vida Sunscreen3785 mL in 1 BOTTLE, PUMPLOTION37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59555-106PURA VIDA SUNSCREEN (ZINC OXIDE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [R & R LOTION, INC]3Legacy NDC, 3 package rows20210128_de1ae98f-8c32-49c5-a22a-c342243a2979.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59555-10659555-106-03, 59555-106-11, 59555-106-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
44d5e9f0-2de1-47d3-80e9-7b01fb2cf3a1de1ae98f-8c32-49c5-a22a-c342243a29792021-01-15WarningsExact identifier
spl id: 44d5e9f0-2de1-47d3-80e9-7b01fb2cf3a1
spl set id: de1ae98f-8c32-49c5-a22a-c342243a2979

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.