SUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE- octisalate 5%, octocrylene 3%, zinc oxide 10.5% lotion

Sun Shades Mineral Plus Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN SHADES MINERAL PLUS SUNSCREEN  WITH ZINC OXIDE
octisalate 5%, octocrylene 3%, zinc oxide 10.5% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-218
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.535 g  in 177 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.45 g  in 177 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-218-06	177 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/27/2012

Labeler - Melaleuca Inc. (139760102)

Registrant - Melaleuca Inc. (079711683)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca Inc.		079711683	manufacture(54473-218)