Sun Shades Mineral Plus Sunscreen

Manufacturer: Melaleuca Inc.
Effective date: 2025-12-31
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:30:24

Label at a glance#

ProductSun Shades Mineral Plus Sunscreen with Zinc Oxide

Active ingredientOCTISALATE, OCTOCRYLENE, ZINC OXIDE

Label structure12 sections

Indications and 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

Dosage and administration

■ 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 protec...

Storage and handling

■ 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)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

■ 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

STORAGE AND HANDLING SECTION

■ 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

INACTIVE INGREDIENT SECTION

water (aqua/eau), caprylic/capric triglyceride, cetearyl alcohol, isoeicosane, C12-15 alkyl benzoate, glycerin, dicaprylyl carbonate, polyester-7, butyrospermum parkii (shea) butter, pentylene glycol, phenyl trimethicone, phenoxyethanol, neopentyl glycol diheptanoate, beeswax (cera alba), ceteth-10 phosphate, dicetyl phosphate, sucrose distearate, aleurites moluccana seed oil, cetyl alcohol, sodium chloride, potassium cetyl phosphate, xanthan gum, fragrance (parfum), potassium sorbate, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, polyhydroxystearic acid, hydrogenated palm glycerides, trisodium ethylenediamine disuccinate, bisabolol, disodium lauriminodipropionate tocopheryl phosphates, macadamia ternifolia seed oil, sodium hydroxide, ascorbyl palmitate, tocopheryl acetate, benzyl salicylate, coumarin, linalool

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun Shades Mineral Sunscreen SPF 30 label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-218-06	2020-03-19	C162847	48780-1	9d75b9cf-f99b-f424-e053-dadaa90a57ce	Sun Shades Mineral Plus SPF 30+ Sunscreen
54473-218-06	2020-01-31	C162847	48780-1	9d75b9cf-f99b-f424-e053-dadaa90a57ce	Sun Shades Mineral Plus SPF 30+ Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-218-06	Sun Shades Mineral Plus Sunscreenwith Zinc Oxide	177 mL in 1 TUBE	LOTION	177		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	2
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	2
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	2
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	2
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	2
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	2
BIXA ORELLANA SEED	INACTIVE INGREDIENT	O87354RZ5A	2
CETETH-10 PHOSPHATE	INACTIVE INGREDIENT	4E05O5N49G	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	2
DICAPRYLYL CARBONATE	INACTIVE INGREDIENT	609A3V1SUA	2
DIHEXADECYL PHOSPHATE	INACTIVE INGREDIENT	2V6E5WN99N	2
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES	INACTIVE INGREDIENT	0K5Y9U1P6M	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
HYDROGENATED PALM GLYCERIDES	INACTIVE INGREDIENT	YCZ8EM144Q	2
ISOEICOSANE	INACTIVE INGREDIENT	AR294KAG3T	2
ISOSTEARIC ACID	INACTIVE INGREDIENT	X33R8U0062	2
KUKUI NUT OIL	INACTIVE INGREDIENT	TP11QR7B8R	2
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	2
MACADAMIA OIL	INACTIVE INGREDIENT	515610SU8C	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	2
NEOPENTYL GLYCOL DIHEPTANOATE	INACTIVE INGREDIENT	5LKW3C543X	2
PENTYLENE GLYCOL	INACTIVE INGREDIENT	50C1307PZG	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	2
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	2
SHEANUT OIL	INACTIVE INGREDIENT	O88E196QRF	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	2
SUCROSE DISTEARATE	INACTIVE INGREDIENT	33X4X4B90S	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

Sun Shades Mineral Plus Sunscreen with Zinc Oxide
OCTISALATE 5%, OCTOCRYlENE 3%, ZINC OXIDE 10.5%
NEOPENTYL GLYCOL DIHEPTANOATE
PENTYLENE GLYCOL
PHENOXYETHANOL
PHENYL TRIMETHICONE
POTASSIUM CETYL PHOSPHATE
POTASSIUM SORBATE
SHEANUT OIL
SODIUM CHLORIDE
SUCROSE DISTEARATE
.ALPHA.-TOCOPHEROL ACETATE
WATER
XANTHAN GUM
YELLOW WAX
OCTISALATE
OCTOCRYLENE
ZINC OXIDE
SODIUM HYDROXIDE
ALKYL (C12-15) BENZOATE
ASCORBYL PALMITATE
CETETH-10 PHOSPHATE
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
DICAPRYLYL CARBONATE
DIHEXADECYL PHOSPHATE
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES
GLYCERIN
HYDROGENATED PALM GLYCERIDES
ISOEICOSANE
ISOSTEARIC ACID
KUKUI NUT OIL
LEVOMENOL
MACADAMIA OIL
MEDIUM-CHAIN TRIGLYCERIDES
TRISODIUM ETHYLENEDIAMINE DISUCCINATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54473-218	54473-218-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NEOPENTYL GLYCOL DIHEPTANOATE	5LKW3C543X	IACT
PENTYLENE GLYCOL	50C1307PZG	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
POTASSIUM CETYL PHOSPHATE	03KCY6P7UT	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
SHEANUT OIL	O88E196QRF	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SUCROSE DISTEARATE	33X4X4B90S	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
WATER	059QF0KO0R	IACT
XANTHAN GUM	TTV12P4NEE	IACT
YELLOW WAX	2ZA36H0S2V	IACT
OCTISALATE	4X49Y0596W	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
SODIUM HYDROXIDE	55X04QC32I	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
ASCORBYL PALMITATE	QN83US2B0N	IACT
CETETH-10 PHOSPHATE	4E05O5N49G	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETYL ALCOHOL	936JST6JCN	IACT
DICAPRYLYL CARBONATE	609A3V1SUA	IACT
DIHEXADECYL PHOSPHATE	2V6E5WN99N	IACT
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES	0K5Y9U1P6M	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYDROGENATED PALM GLYCERIDES	YCZ8EM144Q	IACT
ISOEICOSANE	AR294KAG3T	IACT
ISOSTEARIC ACID	X33R8U0062	IACT
KUKUI NUT OIL	TP11QR7B8R	IACT
LEVOMENOL	24WE03BX2T	IACT
MACADAMIA OIL	515610SU8C	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATE	YA22H34H9Q	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	LOTION / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ISOSTEARIC ACID	ISOSTEARIC ACID	X33R8U0062	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
SUCROSE DISTEARATE	SUCROSE DISTEARATE (HLB 5)	33X4X4B90S	CREAM / TOPICAL		25 mg	Exact identifier — unii+route 2 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SOLUTION / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
ISOSTEARIC ACID	ISOSTEARIC ACID	X33R8U0062	GEL / TOPICAL		20 mg	Exact identifier — unii+route 6 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SYSTEM / TOPICAL	0.04 mg		Exact identifier — unii+route 6 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii+route 2 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	CREAM / TOPICAL	0.02 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ISOSTEARIC ACID	ISOSTEARIC ACID	X33R8U0062	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ISOSTEARIC ACID	ISOSTEARIC ACID	X33R8U0062	CREAM / TOPICAL		100 mg	Exact identifier — unii+route 6 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SYSTEM / TOPICAL	0.04 mg		Exact identifier — unii+route 6 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SOLUTION / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCROSE DISTEARATE	SUCROSE DISTEARATE (HLB 5)	33X4X4B90S	CREAM / TOPICAL		25 mg	Exact identifier — unii+route 2 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	CREAM / TOPICAL	0.02 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
ISOSTEARIC ACID	ISOSTEARIC ACID	X33R8U0062	CREAM / TOPICAL		100 mg	Exact identifier — unii+route 6 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii+route 2 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	LOTION / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ISOSTEARIC ACID	ISOSTEARIC ACID	X33R8U0062	GEL / TOPICAL		20 mg	Exact identifier — unii+route 6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Shades Mineral Plus Sunscreen with Zinc Oxide	OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%	Melaleuca Inc.	8886cbd0-ed2b-4a2b-a724-a0d4f12296c9	2025-12-31	Warnings	Exact identifier ndc (package): 54473-218-06 ndc (product): 54473-218 ndc11 (package): 54473021806 spl id: 4747f511-f270-0585-e063-6394a90a2224 spl set id: 8886cbd0-ed2b-4a2b-a724-a0d4f12296c9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.