Label: LBEL DIVINE LIP GLOSS SPF 15- octinoxate and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-121-01 - 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 November 16, 2011
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- Active Ingredients
- Purpose
- Uses
- Warnings
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Inactive Ingredients
Hydrogenated polyisobutene, diisopropyl dimer dilinoleate, isostearyl neopentanoate, cera alba (beeswax), silica dimethyl silylate, parfum (fragrance), parfum (fragrance), glycerin, prunus amygdalus dulcis oil (prunus amygdalus dulcis (sweet almond) oil), tocopheryl acetate, cocos nucifera oil (cocos nucifera (coconut) oil), aloe barbadensis leaf extract, hydrogenated vegetable oil, propylparaben, methylparaben, sodium saccharin, bht, citrus limon peel cera (citrus limon (lemon) peel wax), citrus limon peel oil (citrus limon (lemon) peel oil), citrus aurantium dulcis peel oil (citrus aurantium dulcis (orange) peel oil), citrus aurantium dulcis peel cera (citrus aurantium dulcis (orange) peel wax). May Contain: CI 77019 (mica), CI 15850 (red 7 lake), CI 77891 (titanium dioxide ), CI 77491, CI 77492, CI 77499 (iron oxides), CI 19140 (yellow 5 lake), CI 16035 (red 40 lake), CI 42090 (blue 1 lake), CI 75470 (carmine), talc, palmitic acid.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 12 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
LBEL DIVINE LIP GLOSS SPF 15
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 mL in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.03 mL in 1 mL Inactive Ingredients Ingredient Name Strength diisopropyl dilinoleate (UNII: 5323S7S2LR) isostearyl neopentanoate (UNII: 411THY156Q) yellow wax (UNII: 2ZA36H0S2V) silica dimethyl silylate (UNII: EU2PSP0G0W) glycerin (UNII: PDC6A3C0OX) almond oil (UNII: 66YXD4DKO9) alpha-tocopherol acetate (UNII: 9E8X80D2L0) coconut oil (UNII: Q9L0O73W7L) aloe vera leaf (UNII: ZY81Z83H0X) propylparaben (UNII: Z8IX2SC1OH) methylparaben (UNII: A2I8C7HI9T) saccharin sodium (UNII: SB8ZUX40TY) butylated hydroxytoluene (UNII: 1P9D0Z171K) lemon peel wax (UNII: 20G0UPO0TI) lemon oil (UNII: I9GRO824LL) orange oil (UNII: AKN3KSD11B) orange peel wax (UNII: 0U715N387C) mica (UNII: V8A1AW0880) D&C red no. 7 (UNII: ECW0LZ41X8) titanium dioxide (UNII: 15FIX9V2JP) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) FD&C yellow no. 5 (UNII: I753WB2F1M) FD&C red no. 40 (UNII: WZB9127XOA) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) cochineal (UNII: TZ8Z31B35M) talc (UNII: 7SEV7J4R1U) palmitic acid (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-121-01 12 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 11/14/2011 Labeler - Ventura International Ltd. (San Juan, P.R) (603192787) Establishment Name Address ID/FEI Business Operations Bel Star, S. A.(Colombia) 880160197 MANUFACTURE(14783-121) Establishment Name Address ID/FEI Business Operations Yobel Supply Chain Management (Peru) 934116930 MANUFACTURE(14783-121)
