LIP CONDITIONER SPF 15 MERLE NORMAN- octinoxate and octisalate jelly 
Merle Norman

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.

----------

Merle Norman Lip Conditioner SPF 15

Active ingredients           Purpose

OCTINOXATE 7.5%      Sunscreen

OCTISALATE 5.0%       Sunscreen

Uses
· helps prevent sunburn

· Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.

· Stop use and ask a doctor if rash occurs and persists

WARNINGS
Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Warnings

· For external use only
· Do not use on damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.

Directions
· Apply liberally 15 minutes before sun exposure
· Reapply at least every 2 hours
· Use a water resistant sunscreen if swimming or sweating
· Children under 6 months of age: Ask a doctor

Ricinus communis ( castor) seed oil, macadamia ternifolia seed oil, ozokerite, euphorbia cerifera ( candelilla) wax, copernicia cerifera ( carnauba) wax, astrocaryum murumuru seed butter, isopropyl lanolate, jojoba esters, wheat germ glycerides, oleyl alcohol, isodecyl oleate, butyspermum parkii (shea ) butter, elaeis guineensis (palm) butter, punica granatum extract, acacia decurrens flower wax, helianthus annuus (sunflower) seed wax, simmondsia chinensis (jojoba) seed wax, jojoba oil, c12-15 alkyl benzoate, polyglyceryl-3 esters, polyhydroxystearic acid, stearic acid, BHT, aluminum oxide, titanium dioxide, Fragrance (parfum) 030411






image of primary

Lip Conditioner

SPF 15

Merle Norman

3.7 g  net. wt. .13 oz.






image of sticker label

LIP CONDITIONER SPF 15  MERLE NORMAN
octinoxate,octisalate jelly
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57627-107
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE.278 g  in 3.7 g
OCTISALATE (OCTISALATE) OCTISALATE.185 g  in 3.7 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
MACADAMIA OIL 
CERESIN 
CANDELILLA WAX 
ASTROCARYUM MURUMURU SEED BUTTER 
SHEA BUTTER 
ELAEIS GUINEENSIS FRUIT BUTTER 
HELIANTHUS ANNUUS SEED WAX 
ALKYL (C12-15) BENZOATE 
STEARIC ACID 
BUTYLATED HYDROXYTOLUENE 
ALUMINUM OXIDE 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-107-021 in 1 BOX
1NDC:57627-107-013.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/21/2011
Labeler - Merle Norman (008479388)
Registrant - Merle Norman (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman008479388manufacture(57627-107)

Revised: 5/2013
Document Id: 59687715-de91-423f-8477-293e02ef4ea8
Set id: b28459dc-c2df-4f8b-8b37-0090e223e6e9
Version: 7
Effective Time: 20130501
 
Merle Norman