Sun Shades Mineral Plus Sunscreen with Zinc Oxide

Sun Shades Mineral Plus Sunscreen with Zinc Oxide

Drug Labeling and Warnings

Drug Details

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SUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE- octisalate 5%, octocrylene 3%, zinc oxide 10.5% lotion 
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 Plus Sunscreen with Zinc Oxide

Active ingredients

Octisalate 5%, Octocrylene 3%, Zinc Oxide 10.5%

Purpose

Sunscreen

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

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.

Stop use and ask a doctor if rash occurs

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

Directions

■ apply liberally and spread evenly by hand 15 minutes before sun exposure

■ reapply:

■ after 80 minutes of swimming or sweating

■ immediately after towel drying

■ at least every 2 hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early signs of aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF value of 15 or higher and other sun protection measures including:

■ limit time in the sun, especially from 10 AM-2 PM

■ wear long-sleeve shirts, pants, hats, and sunglasses

■ children under 6 months of age: ask a doctor

Other information

■ protect this product from excessive heat and direct sun

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

Inactive ingredients

aleurites meluccana 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, dicaprylyl carbonate, dicetyl phosphate, disodium EDTA, disodium lauriminodipropionate tocopheryl phosphates, glycerin, hydrogenated palm glycerides, isoeicosane, isostearic acid, lecithin, macadamia ternifolia seed oil, neopentyl glycol diheptanoate, parfum, pentylene glycol, phenoxyethanol, phenyl trimethicone, polyester-7, polyglyceryl-3 polyricinoleate, polyhydroxystearic acid, potassium cetyl phosphate, potassium sorbate, sodium chloride, sucrose distearate, tocopherol, triethanolamine, water, xanthan gum

Image of tube

SUN SHADES MINERAL PLUS SUNSCREEN  WITH ZINC OXIDE
octisalate 5%, octocrylene 3%, zinc oxide 10.5% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54473-218
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE9.225 g  in 177 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.535 g  in 177 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.45 g  in 177 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BIXA ORELLANA SEED (UNII: O87354RZ5A)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
ISOEICOSANE (UNII: AR294KAG3T)  
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)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SHEANUT OIL (UNII: O88E196QRF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SUCROSE DISTEARATE (UNII: 33X4X4B90S)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54473-218-06177 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/27/2012
Labeler - Melaleuca Inc. (139760102)
Registrant - Melaleuca Inc. (079711683)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca Inc.079711683manufacture(54473-218)

Revised: 3/2018
 
Melaleuca Inc.


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