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Sunzen

Prime Packaging, Inc.
Prime Packaging, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

Sunzen

SUNZEN

RELAX IN THE SUN

8

TINTED

SUNSCREEN

CONTINUOUS SPRAY

BROAD SPECTRUM SPF 8

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

6 FL. OZ / 177 mL

Active ingredients

Avobenzone 1 %, Octisalate 3 %, Octocrylene 0.85 %, and Oxybenzone 1 %

Purpose

Purpose

Sunscreen

Sunzen Uses

  • helps prevent sunburn

Warnings


Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For exernal use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

  • Keep away from face to avoid breathing it.
  • Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 1200F

Stop use and ask a doctor if rash occurs.

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

Flammable: Do not use near heat, flame or while smoking.

Directions

  • spray liberally and spread by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy conditions
  • use in well-ventilated areas.
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months: Ask a doctor

Inactive Ingredients

Blue 1 (CI 42090), C12-15 Alkyl Benzoate, Fragrance (Parfum), Red 40 (CI 16035), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water (Aqua), Yellow 5 (CI 19140)

Sunzen Other information

  • protect this product from excesive heat and direct sun
  • may stain some fabrics

Questions or Comments? Biocycle Laboratories, Inc.

 16363 NW 49 Avenue, Miami FL 33014

Distributed by: Biocycle Laboratories, Inc. Miami Fl 33014

Made in USA

Sunzen

Avobenzone, Octisalate, Octocrylene and Oxybenzone SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13630-0045
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 8.2 mg
OCTISALATE OCTISALATE 24.6 mg
OCTOCRYLENE Octocrylene 6.97 mg
OXYBENZONE OXYBENZONE 8.2 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
ALKYL (C12-15) BENZOATE
FD&C RED NO. 40
water
FD&C YELLOW NO. 5
ALCOHOL

Product Characteristics

Color
orange

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13630-0045-4 177 in 1 CAN

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-03-21


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