Label: LBEL UV DEFENSE 365- homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide lotion/shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-094-01, 14783-094-02, 14783-094-03, 14783-094-04, view more14783-094-05 - Packager: Ventura International Ltd. (San Juan, P.R)
- 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 August 26, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
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Other information
- High sun protection product.
- Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.
- Apply the product with your fingertips. Use every morning before exposure to UVA and UVB radiation or whenever needed.
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Inactive ingredients
aqua (water), dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bisethylhexyl hydroxydimethoxy benzylmalonate, dimethicone, tocopheryl acetate, silica, methicone, peg-8, ceteareth-12, ceteareth-20, propylene glycol, phenoxyethanol, methylparaben, ambrosia peruviana leaf extract, cetearyl alcohol, cetyl palmitate, xanthan gum, caprylyl glycol, mica, propylparaben, butylene glycol, helianthus annuus seed extract (helianthus annuus (sunflower) seed extract), ppg-1-peg-9-lauryl glycol ether, chlorphenesin, triethoxycaprylylsilane, cyclopentasiloxane, hedera helix extract (hedera helix (ivy) leaf/ stem extract), phytic acid, sodium polyacrylate.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Carton
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INGREDIENTS AND APPEARANCE
LBEL UV DEFENSE 365
homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-094 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.05 g in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.04 g in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0624 g in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.0388 g in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) dicaprylyl carbonate (UNII: 609A3V1SUA) propylheptyl caprylate (UNII: 991Z19V2OD) glyceryl monostearate (UNII: 230OU9XXE4) potassium cetyl phosphate (UNII: 03KCY6P7UT) cyclomethicone 6 (UNII: XHK3U310BA) glycerin (UNII: PDC6A3C0OX) sorbitan monostearate (UNII: NVZ4I0H58X) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY) silicon dioxide (UNII: ETJ7Z6XBU4) cetostearyl alcohol (UNII: 2DMT128M1S) ceteareth-12 (UNII: 7V4MR24V5P) cetyl palmitate (UNII: 5ZA2S6B08X) polyethylene glycol 400 (UNII: B697894SGQ) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) ambrosia peruviana leaf (UNII: 458F79CGBF) xanthan gum (UNII: TTV12P4NEE) caprylyl glycol (UNII: 00YIU5438U) mica (UNII: V8A1AW0880) propylparaben (UNII: Z8IX2SC1OH) triethoxycaprylylsilane (UNII: LDC331P08E) butylene glycol (UNII: 3XUS85K0RA) sunflower seed (UNII: R9N3379M4Z) chlorphenesin (UNII: I670DAL4SZ) cyclomethicone 5 (UNII: 0THT5PCI0R) hedera helix top (UNII: 379040L9FW) phytic acid (UNII: 7IGF0S7R8I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-094-02 1 in 1 BOX 1 NDC:14783-094-01 30 mL in 1 BOTTLE 2 NDC:14783-094-04 1 in 1 BOX 2 NDC:14783-094-03 3 mL in 1 BOTTLE 3 NDC:14783-094-05 1 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/29/2011 Labeler - Ventura International Ltd. (San Juan, P.R) (603192787) Establishment Name Address ID/FEI Business Operations MF Productions Saumur 266769145 MANUFACTURE