Label: EXTREME SPORT SPF 70- avobenzone - 3.00% homosalate - 15.00% octisalate - 5.00% octocrylene - 4.00% oxybenzone - 6.00% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-727-04 - Packager: Top Care
- 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 July 17, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients Purpose
- PURPOSE
- INDICATIONS & USAGE
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WarningsFor 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 temperature 120FStop use and ask a doctor if rash occurs
- KEEP OUT OF REACH OF CHILDREN
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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
• 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTREME SPORT SPF 70
avobenzone - 3.00% homosalate - 15.00% octisalate - 5.00% octocrylene - 4.00% oxybenzone - 6.00% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-727 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 g Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 15 g in 100 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 4 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 6 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BRINE SHRIMP (UNII: 3ID50N77DH) Ascorbyl Palmitate (UNII: QN83US2B0N) Butyloctyl Salicylate (UNII: 2EH13UN8D3) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Glycerin (UNII: PDC6A3C0OX) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-727-04 141 g in 1 CAN; Type 0: Not a Combination Product 07/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2013 Labeler - Top Care (006935977) Registrant - Product Manufacturer Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Manufacturer Mfg. 927768135 manufacture(36800-727) , label(36800-727)
