Maybelline New York Baby Lips Moisturizing Lip Balm SPF 20

Dosage form: lipstick
Ingredients: Octinoxate 0.33g in 4.4g, Octisalate 0.132g in 4.4g
Labeler: L'Oreal USA Products Inc
NDC Code: 49967-452

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 Facts

Active ingredients

Octinoxate 7.5%

Octisalate 3%

Uses

HELPS PREVENT SUNBURN.

HIGHER SPF GIVES MORE SUNBURN PROTECTION

Directions

APPLY BEFORE SUN EXPOSURE.

Warnings

STOP USE AND ASK A DOCTOR IF SKIN RASH OR IRRITATION DEVELOPS AND LASTS.

Inactive ingredients

polybutene, octyldodecanol, isopropyl myristate, petrolatum, polyethylene, ozokerite, butyrospermum park II (shea) butter, diisostearyl malate, euphorbia cerifera (candelilla) wax, vp/hexadecene copolymer, silica dimethyl silylate, fragrance, calcium aluminum borosilicate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tocopherol, tocopheryl acetate, alumina, flavor, silica, isopropyl palmitate, pentaerythrityl tetraisostearate, limonene, synthetic fluorphlogopite, calcium sodium borosilicate, benzyl benzoate, centella asiatica extract, aluminum hydroxide, citral, linalool, hexyl cinnamal, tin oxide, geraniol, eugenol, aloe barbadensis leaf extract, calcium pantothenate, honey, ascorbic acid, dimethicone, sodium chondroitin sulfate, atelocollagen; may contain: titanium dioxide, mica, red 28 lake, iron oxides, red 7, red 22 lake, yellow 5 lake, blue 1 lake, yellow 6 lake, carmine

MAYBELLINE NEW YORK  BABY LIPS MOISTURIZING LIP BALM SPF 20
octinoxate octisalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-452
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.33 g  in 4.4 g
Octisalate (Octisalate) Octisalate0.132 g  in 4.4 g
Packaging
#Item CodePackage Description
1NDC:49967-452-011 TUBE (TUBE) in 1 BLISTER PACK
14.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2011
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIOperations
L'Oreal USA Products Inc624244349manufacture

Revised: 03/2012
 
L'Oreal USA Products Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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