Label: BROAD SPECTRUM SPF 70 SUNSCREEN PREFERRED PLUS PHARMACY- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
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Contains inactivated NDC Code(s)
NDC Code(s): 61715-030-06 - Packager: Kinray Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 15, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only. Flammable: do not use near heat, flame, or while smoking. 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. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 degrees F. Stop use and ask a doctor if rash occurs.
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DOSAGE & ADMINISTRATION
Directions
Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours. 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 area.
Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin again. 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, specially from 10am - 2pm, wear long-sleeve shirts, pants, hats, and sunglasses.
Children under 6 months: ask a doctor.
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BROAD SPECTRUM SPF 70 SUNSCREEN PREFERRED PLUS PHARMACY
avobenzone, homosalate, octisalate, octocrylene, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CAPRYLIC/CAPRIC ACID (UNII: DI775RT244) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-030-06 177 mL in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/15/2013 Labeler - Kinray Inc. (012574513)
