SPF 20 Natural

Dosage form: liquid
Ingredients: TITANIUM DIOXIDE 2.9445g in 44.4mL
Labeler: Melaleuca, Inc.
NDC Code: 54473-172

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.

Label of Tinted Moisturizer Natural

Active ingredients       Purpose
Titanium Dioxide 6.5%.....Sunscreen

Use

  • Provides moderate protection against sunburn

Warnings

For External use only
When using this product
keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash or irritation develops and lasts.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply evenly before sun exposure and as needed. Apply after cleanser, toner, and serum. Blend outward for an even finish. Can be worn as a moisturizer and foundation in one or as a lightweight foundation.
  • Children under 6 months of age: ask a doctor.

Other information
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Other information

  • dermatologist and allergy tested

Other information

  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Inactive ingredients

aqua (water/eau), C13-C16 isoparaffin, C12-C14 isoparaffin, aluminum hydroxide, C13-15 alkane, isostearic acid, cetyl alcohol, cyclopentasiloxane, polyethylene, PEG/PPG-20/15 dimethicone, phenyl methicone, glycine soja (soybean) oil, hydrogenated cottonseed oil, propylheptyl caprylate, cetyl palmitate, glycerin, beta-glucan, polysorbate 80, octyldodecylneopentanoate, butyrospermum parkii shea butter, penylene glycol, polymethylsilsesquioxane tetrapeptide-21, sodium polyacrylate, potassium cetyl phosphate, hydrogenated palm glycerides, ethylhexylglycerin, tetrahexyldecyl ascorbate, lonicera japonica (honeysuckle) flower extract, lonicera caproifolium (honeysuckle) flower extract, carnosine, aloe barbadensis leaf juice powder, tocopheryl acetate vitis vinifera (grape) leaf extract, cucumis sativus (cucumber) fruit extract, tremella fuciformis sporocap extract, aminomethyl propanol, disodium EDTA, butylene glycol, sodium C14-16 olefin sulfonate [+ titanium dioxide (CI 77891), iron oxides (CI 77491, CI 77492, CI 77499)]

SPF 20  NATURAL
titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-172
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.9445 g  in 44.4 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
ALUMINUM HYDROXIDE 
ISOSTEARIC ACID 
Cetyl Alcohol 
Cyclomethicone 5 
SOYBEAN OIL 
HYDROGENATED COTTONSEED OIL 
CETYL PALMITATE 
POLYSORBATE 80 
OCTYLDODECYL NEOPENTANOATE 
SHEA BUTTER 
PENTYLENE GLYCOL 
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) 
POTASSIUM CETYL PHOSPHATE 
ETHYLHEXYLGLYCERIN 
TETRAHEXYLDECYL ASCORBATE 
LONICERA DASYSTYLA FLOWER BUD 
LONICERA CAPRIFOLIUM FLOWER 
CARNOSINE 
ALOE VERA LEAF 
Vitamin E Acetate 
GRAPE 
CUCUMBER 
AMINOMETHYLPROPANOL 
EDETATE DISODIUM 
BUTYLENE GLYCOL 
SODIUM C14-16 OLEFIN SULFONATE 
DIMETHICONE 
Packaging
#Item CodePackage Description
1NDC:54473-172-011 TUBE (TUBE) in 1 BOX
144.4 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/08/2010
Labeler - Melaleuca, Inc. (139760102)

Revised: 01/2011
 
Melaleuca, 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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