Label: FAIR AND SQUARE ULTRA PROTECTION BROAD SPECTRUM SPF 15- avobenzone, homosalate, octisalate, and oxybenzone aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 13630-0080-4 - Packager: Prime Packaging, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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Warnings
When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Content is under pressure - do not pumcture or incinerate. Do not store at temperature above 120°F.
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Directions
- Hold container 4-6 inches from the skin & spray to apply. Spread evenly by hand 15 minuted before sun exposure
- DO NOT spray directly into face. Spray on hands then apply to face.
- Do not apply in windy conditions.
- Use in a well-ventilated area
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 & early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and othre sun protection measures including:
- limit time in the sun, especially from 10am - 2 pm
- wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor
- Inactive ingredients
- Other Information
- PRINCIPAL DISPLAY PANEL - 177 mL Can Label
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INGREDIENTS AND APPEARANCE
FAIR AND SQUARE ULTRA PROTECTION BROAD SPECTRUM SPF 15
avobenzone, homosalate, octisalate, and oxybenzone aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 16.1 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 80.3 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40.2 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 24.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BUTYL MALEURATE (UNII: 6FUA0H660I) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0080-4 177 mL in 1 CAN; Type 0: Not a Combination Product 02/28/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/28/2014 Labeler - Prime Packaging, Inc. (805987059) Registrant - Prime Packaging, Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(13630-0080) , analysis(13630-0080) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0080) , pack(13630-0080)
