Label: NO-AD BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene aerosol
- NDC Code(s): 13630-0270-5
- 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 April 6, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
• For external use only
• Flammable. Do not use near heat, flame or while smoking. Contents under pressure. Do not puncture or incinerate. Do not sotre at temperatures above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
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Directions
• Shake well. 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 and avoid inhalation
• Children under 6 months of age: ask a doctor
• 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 value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 am - 2 pm
• Wear long-sleeved shirts, pants, hats and sunglasses
- Inactive Ingredients
- Other Information
- NO-AD SPF 50 Kids Sunscreen Spray
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INGREDIENTS AND APPEARANCE
NO-AD BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0270 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g Inactive Ingredients Ingredient Name Strength MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) ALCOHOL (UNII: 3K9958V90M) VINYL ACETATE (UNII: L9MK238N77) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) WATER (UNII: 059QF0KO0R) MONOBUTYL MALEATE (UNII: F2LD7FVO1L) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color yellow (Light Yellow to Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0270-5 255 g in 1 CAN; Type 0: Not a Combination Product 04/06/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 04/06/2023 Labeler - Prime Packaging Inc (805987059) Registrant - Prime Packaging Inc (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises 101946028 analysis(13630-0270) , label(13630-0270) , manufacture(13630-0270) , pack(13630-0270) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc 805987059 label(13630-0270) , pack(13630-0270)
