Pura vida sunscreen lotion

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

Active Ingredients Purpose
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 section

Do not useon 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 doctorif 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

  • 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

Ingredients and appearance - Product information

Pura vida sunscreen lotion- Zinc oxide, octinoxate, octisalate, and oxybenzone

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 59555-106
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc oxide - UNII: SOI2LOH54Z ) 64 mgin 1 mL
Octinoxate ( UNII: 4Y5P7MUD51)( Octinoxate - UNII: 4Y5P7MUD51 ) 59 mgin 1 mL
Octisalate ( UNII: 4X49Y0596W)( Octisalate - UNII: 4X49Y0596W ) 38 mgin 1 mL
Oxybenzone ( UNII: 95OOS7VE0Y)( Oxybenzone - UNII: 95OOS7VE0Y ) 47 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Xanthan gum ( UNII: TTV12P4NEE)
Propylene glycol ( UNII: 6DC9Q167V3)
Methylparaben ( UNII: A2I8C7HI9T)
Diethylhexyl adipate ( UNII: MBY1SL921L)
Ethylhexyl palmitate ( UNII: 2865993309)
Ethylhexyl stearate ( UNII: EG3PA2K3K5)
Cetostearyl alcohol ( UNII: 2DMT128M1S)
Polyoxyl 20 cetostearyl ether ( UNII: YRC528SWUY)
.alpha.-tocopherol ( UNII: H4N855PNZ1)
Imidurea ( UNII: M629807ATL)
Diethanolamine oleth-3 phosphate ( UNII: Y67NX5905E)
Glyceryl monostearate ( UNII: 230OU9XXE4)
Peg-100 stearate ( UNII: YD01N1999R)
Propylparaben ( UNII: Z8IX2SC1OH)

Product Characteristics

Color WHITE

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 59555-106-03 50mL in 1 BOTTLE, PUMP 2015/12/21
2 NDC: 59555-106-11 3785mL in 1 BOTTLE, PUMP 2015/12/21
3 NDC: 59555-106-08 3785mL in 1 BOTTLE, PUMP 2015/12/21

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part352 USA 2015/12/21

Labeler - R & R Lotion, Inc( 062979000)

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