SUN SHADES MINERAL PLUS SUNSCREEN- octisalate and zinc oxide cream 
Melaleuca, Inc.

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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Sun Shades Mineral SPF 30+ Content of Label

Active ingredient
Octisalate 5%, Zinc oxide 10%

Purpose
Sunscreen

Uses

Warnings
For external use only

When using this product keep out of the 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

Inactive ingredients
aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, caprylic/capric triglyceride, cera alba, cetearyl alcohol, ceteth-10 phosphate, cetyl alcohol, cetyl ethylhexanoate, dicaprylyl carbonate, dicetyl phosphate, disodium EDTA, disodium lauriminodipropionate tocopheryl phosphates, glycerin, hydrogenated palm glycerides, isoeicosane, isostearic acid, macadamia ternifolia seed oil, neopentyl glycol diheptanoate, parfum, pentylene glycol, phenoxyethanol, phenyl trimethicone, polyester-7, polyhydroxystearic acid, potassium cetyl phosphate, potassium sorbate, sodium chloride, sucrose distearate, tocopherol, triethanolamine, water, xanthan gum

image of label
SUN SHADES  MINERAL PLUS SUNSCREEN
octisalate and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-164
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE9.225 g  in 177 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE18.45 g  in 177 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BIXA ORELLANA SEED (UNII: O87354RZ5A)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
LEVOMENOL (UNII: 24WE03BX2T)  
MACADAMIA OIL (UNII: 515610SU8C)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SHEA BUTTER (UNII: K49155WL9Y)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-164-06177 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2009
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.139760102manufacture

Revised: 2/2011
Document Id: 14c560f4-08f8-4f3a-9eed-3014820bfd78
Set id: 6b4d59e2-04f5-4a37-a8fd-062b1dca0794
Version: 1
Effective Time: 20110223
 
Melaleuca, Inc.