Label: QUICK DRY BODY BROAD SPECTRUM SPF40 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X- avobenzone, octisalate, and octocrylene spray
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Contains inactivated NDC Code(s)
NDC Code(s): 49358-556-01 - Packager: MDSolarSciences
- 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 June 4, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
- Flammable
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Directions
- Apply liberally 15 minutes before sun exposure
- Spray on hands and rub well into face and scalp
- Reapply:
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- After 80 minutes of swimming or sweating
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- Immediately after towel drying
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- At least every 2 hours
- Children under 6 months: Ask a doctor
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Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
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- Limit time in the sun, especially from 10a.m. – 2p.m.
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- Wear long-sleeved shirts, pants, hats and sunglasses.
- Other Information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 148 mL Can Carton
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INGREDIENTS AND APPEARANCE
QUICK DRY BODY BROAD SPECTRUM SPF40 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X
avobenzone, octisalate, and octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49358-556 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 Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 5 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 2.75 g in 100 g Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Polyester-8 (1400 MW, Cyanodiphenylpropenoyl Capped) (UNII: T9296U138P) Caprylyl Trisiloxane (UNII: Q95M2P1KJL) Diisopropyl Adipate (UNII: P7E6YFV72X) Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: 71DD5V995L) Edetic Acid (UNII: 9G34HU7RV0) Fytic Acid (UNII: 7IGF0S7R8I) Phyllanthus Emblica Fruit (UNII: YLX4CW2576) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-556-01 1 in 1 CARTON 03/01/2015 1 148 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/01/2015 Labeler - MDSolarSciences (013647301)