Label: PANAMA JACK BROAD SPECTRUM SPF 100 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
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Contains inactivated NDC Code(s)
NDC Code(s): 13630-0124-4 - 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.
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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. Risne 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 120ºF.
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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 well ventilated areas.
- Reapply:
- after 80 minutes of swimming and 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 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor.
- Inactive Ingredients
- Other Information
- Question or comments?
- Panama Jack 100 Broad Spectrum SPF 100 Sunscreen
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INGREDIENTS AND APPEARANCE
PANAMA JACK BROAD SPECTRUM SPF 100 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 26.28 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 131.4 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 43.8 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 87.6 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 52.56 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALCOHOL (UNII: 3K9958V90M) VINYL ACETATE (UNII: L9MK238N77) MONOBUTYL MALEATE (UNII: F2LD7FVO1L) 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:13630-0124-4 177 mL in 1 CAN; Type 0: Not a Combination Product 01/24/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/24/2018 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(13630-0124) , analysis(13630-0124) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 label(13630-0124) , pack(13630-0124)
