PRO LASER BODY- octinoxate, titanium dioxide, oxybenzone cream
Zenith Medicosm SL

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.

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Drug Facts

Active Ingredient

Octinoxate 7.5%

Titanium Dioxide 25%

Oxybenzone 6%

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

TOPICAL USE

PRO LASER BODY
octinoxate, titanium dioxide, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42248-130
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42248-130-01	150 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/01/2011

Labeler - Zenith Medicosm SL (464239694)

Registrant - Zenith Medicosm SL (464239694)

Name	Address	ID/FEI	Business Operations
Establishment
Zenith Medicosm SL		464239694	manufacture