OTC Medication Information: SUNZEN Broad Spectrum SPF 30

SUNZEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
Prime Packaging, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Avobenzone 3 %, Homosalate 7.5 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

Purpose

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

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 120 0 F

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 evenly 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
  • 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 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

Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other information

  • protect this product from excesive heat and direct sun
  • avoid spraying on fabrics

Questions or Comments? Biocycle Laboratories, Inc.

16363 NW 49th Avenue, Miami, FL 33014

PRINCIPAL DISPLAY PANEL — 177 mL Can Label

PRINCIPAL DISPLAY PANEL -- 177 mL Can Label
(click image for full-size original)


SUNZEN

RELAX IN THE SUN

30

CONTINUOUS SPRAY

SUNSCREEN

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

6 FL. OZ. / 177mL

SUNZEN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0049
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 25.6 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 63.9 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 42.7 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 23.5 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 17.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL ACETATE
ALCOHOL
Product Characteristics
Color yellow Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13630-0049-4 177 mL in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/01/2013
Labeler — Prime Packaging, Inc. (805987059)
Registrant — Prime Packaging, Inc. (805987059)
Establishment
Name Address ID/FEI Operations
Prime Enterprises, Inc. 101946028 manufacture (13630-0049), analysis (13630-0049)
Establishment
Name Address ID/FEI Operations
Prime Packaging, Inc. 805987059 label (13630-0049), pack (13630-0049)

Revised: 01/2020 Prime Packaging, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.