Label: FAIRMONT BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene aerosol
- NDC Code(s): 13630-0287-4
- Packager: Prime Packaging, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 3, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
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 120F
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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 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 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 10 am - 2 pm
- Wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: ask a doctor
- Inactive Ingredients
- Other Information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAIRMONT BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0287 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.15 g in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.05 g in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.03 g in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.0275 g in 1 g Inactive Ingredients Ingredient Name Strength POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) ALCOHOL (UNII: 3K9958V90M) MINERAL OIL (UNII: T5L8T28FGP) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCONUT OIL (UNII: Q9L0O73W7L) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) MONOBUTYL MALEATE (UNII: F2LD7FVO1L) VINYL ACETATE (UNII: L9MK238N77) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) Product Characteristics Color yellow (Light Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0287-4 156 g in 1 CAN; Type 0: Not a Combination Product 05/03/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/03/2024 Labeler - Prime Packaging, Inc. (805987059) Registrant - Prime Packaging, Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0287) , pack(13630-0287) Establishment Name Address ID/FEI Business Operations Prime Enterprises 101946028 analysis(13630-0287) , manufacture(13630-0287)
