Liquid Makeup SPF 16 Merle Norman

Dosage form: liquid
Ingredients: OCTINOXATE 2.25g in 30mL, OXYBENZONE 0.6g in 30mL
Labeler: Merle Norman
NDC Code: 57627-112

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 Liquid Makeup SPF 16

Active ingredients

OCTINOXATE 7.5%

OXYBENZONE 2.0%

Uses

Helps prevent Sunburn

If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Keep out of reach of children. If Swallowed, get medical help or contact a Poison Control Center right away.

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

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

Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with broad spectrum SPF of 15 or higher and other sun protection measures
including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

Water (aqua), titanium dioxide, butylene glycol, iron oxides, squalane, stearic acid, mica , propylene glycol stearate se, talc, triethanolamine, dimethicone, trilaurin, tocopheryl acetate, ascorbyl palmitate, panthenol, allantoin, silica, lecithin, magnesium aluminium silicate, dea-cetyl phosphate, tricaprylin, propylene glycol dipelargonate , stearyl alcohol, imidazolidinyl urea, methylparaben, cellulose gum, ethylparaben, propylparaben, trisodium edta, BHT 070909

Liquid Makeup

Broad Spectrum

SPF 16

Merle Norman

30 mL 1 FL. OZ.

LIQUID MAKEUP SPF 16  MERLE NORMAN
octinoxate, oxybenzone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-112
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.25 g  in 30 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE0.6 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
BUTYLENE GLYCOL 
FERROUS OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
SQUALANE 
STEARIC ACID 
MICA 
PROPYLENE GLYCOL MONOPALMITOSTEARATE 
TALC 
TROLAMINE 
DIMETHICONE 
TRILAURIN 
ASCORBYL PALMITATE 
PANTHENOL 
ALLANTOIN 
SILICON DIOXIDE 
MAGNESIUM ALUMINUM SILICATE 
DIETHANOLAMINE CETYL PHOSPHATE 
TRICAPRYLIN 
STEARYL ALCOHOL 
IMIDUREA 
METHYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
ETHYLPARABEN 
PROPYLPARABEN 
EDETATE TRISODIUM 
BUTYLATED HYDROXYTOLUENE 
Packaging
#Item CodePackage Description
1NDC:57627-112-021 TUBE in 1 CARTON
1NDC:57627-112-0130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/25/2011
Labeler - Merle Norman (008479388)
Registrant - Merle Norman (008479388)
Establishment
NameAddressID/FEIOperations
Merle Norman008479388manufacture(57627-112)

Revised: 02/2014
 
Merle Norman

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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