Label: PRO LASER BODY- octinoxate, titanium dioxide, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42248-130-01 - Packager: Zenith Medicosm SL
- 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 May 23, 2012
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- Active Ingredient
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Description
PRO LASER BODY EMULSION
SPF 35
Protective body cream formulated with the perfect combination of sunscreens capable of covering a larger area of the solar radiation spectrum. Indicated for use after laser body treatments and surgery, and for skin that has been subjected to aggressive treatments and that needs extreme protection and rapid regeneration
Apply by rubbing into the skin until completely absorbed. Repeat 2 to 3 times a day. Not water resistant.
150ml. 5.1 fl. Oz
- Warning
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRO LASER BODY
octinoxate, titanium dioxide, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42248-130 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 11.25 mL in 150 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 37.5 mL in 150 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 9 mL in 150 mL Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCONUT ACID (UNII: 40U37V505D) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) WHITE WAX (UNII: 7G1J5DA97F) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT) CARBOMER 934 (UNII: Z135WT9208) IMIDUREA (UNII: M629807ATL) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) (2-CARBETHOXYETHYL)DIETHOXY(METHYL)SILANE (UNII: N28HAC3H5P) HYDROXYPROLINE (UNII: RMB44WO89X) ASPARTIC ACID (UNII: 30KYC7MIAI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42248-130-01 150 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/01/2011 Labeler - Zenith Medicosm SL (464239694) Registrant - Zenith Medicosm SL (464239694) Establishment Name Address ID/FEI Business Operations Zenith Medicosm SL 464239694 manufacture