SUN SHADES MINERAL PLUS SUNSCREEN- octisalate and zinc oxide cream

Sun Shades by

Drug Labeling and Warnings

Sun Shades by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Octisalate 5%, Zinc oxide 10%

PURPOSE

Purpose
Sunscreen

INDICATIONS & USAGE

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• for skin highly sensitive to sunburn
• retains SPF after 80 minutes of activity in the water or sweating
  

WARNINGS

Warnings
For external use only

WHEN USING

When using this product keep out of the eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash or irritation develops and lasts

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• apply liberally and evenly to all exposed areas before sun exposure
• reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours.
• children under 6 months of age: ask a doctor
  

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN SHADES  MINERAL PLUS SUNSCREEN
octisalate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-164
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	9.225 g  in 177 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS)	ZINC OXIDE	18.45 g  in 177 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-164-06	177 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2009

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		139760102	manufacture