Label: LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octisalate, octocrylene, and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-804-01, 14783-804-02 - Packager: Ventura International LTD
- 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 22, 2015
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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.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply 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
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Inactive ingredients
WATER, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, GLYCERIN, DIMETHICONE, POTASSIUM CETYL PHOSPHATE, ALBIZIA JULIBRISSIN BARK EXTRACT, BUTYLENE GLYCOL, GLYCERYL STEARATE, PENTYLENE GLYCOL, HYDROGENATED PALM GLYCERIDES, PHENOXYETHANOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, XANTHAN GUM, C20-22 ALKYL PHOSPHATE, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, FRAGRANCE, C20-22 ALCOHOLS, CHLORPHENESIN, HYDROLYZED CERATONIA SILIQUA SEED EXTRACT, ACACIA SENEGAL GUM, SODIUM HYDROXIDE, DISODIUM EDTA, OLIVE OIL AMINOPROPANEDIOL ESTERS, RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS, HYDROXYPROPYL CYCLODEXTRIN, SILICA, PALMITOYL TRIPEPTIDE-38.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Box
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INGREDIENTS AND APPEARANCE
LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15
avobenzone, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-804 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 0.03 g in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ) cyclomethicone 6 (UNII: XHK3U310BA) glycerin (UNII: PDC6A3C0OX) dimethicone (UNII: 92RU3N3Y1O) potassium cetyl phosphate (UNII: 03KCY6P7UT) albizia julibrissin bark (UNII: 0J9G6W44DV) butylene glycol (UNII: 3XUS85K0RA) glyceryl monostearate (UNII: 230OU9XXE4) pentylene glycol (UNII: 50C1307PZG) hydrogenated palm glycerides (UNII: YCZ8EM144Q) phenoxyethanol (UNII: HIE492ZZ3T) hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer (UNII: WB5K9Y35Y9) xanthan gum (UNII: TTV12P4NEE) c20-22 alkyl phosphate (UNII: L4VKP0Y7RP) c20-22 alcohols (UNII: O4M0347C6A) chlorphenesin (UNII: I670DAL4SZ) acacia (UNII: 5C5403N26O) sodium hydroxide (UNII: 55X04QC32I) edetate disodium (UNII: 7FLD91C86K) silicon dioxide (UNII: ETJ7Z6XBU4) palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-804-02 1 in 1 BOX 1 NDC:14783-804-01 50 mL in 1 BOTTLE; 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 06/22/2015 Labeler - Ventura International LTD (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-804)