Label: ESIKA PERFECT SUN- avobenzone, octisalate, octocrylene, and oxybenzone liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-153-01 - Packager: Ventura Corporation, Ltd.
- Category: HUMAN OTC DRUG LABEL
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 26, 2012
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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
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Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Children under 6 months of age: 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 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 a.m.–2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 150 ml Bottle
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INGREDIENTS AND APPEARANCE
ESIKA PERFECT SUN
avobenzone, octisalate, octocrylene, and oxybenzone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-153 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.1 g in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.06 g in 1 mL Inactive Ingredients Ingredient Name Strength cyclomethicone 5 (UNII: 0THT5PCI0R) alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ) dimethicone (UNII: 92RU3N3Y1O) alpha-tocopherol acetate (UNII: 9E8X80D2L0) aloe vera leaf (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-153-01 150 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/24/2012 Labeler - Ventura Corporation, Ltd. (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE