FDA.reportPublic FDA data

Sun Shades Mineral Plus Sunscreen

Product NDC
54473-218
11-digit product format
544730218
Labeler code
54473
Product ID
54473-218_4747f511-f270-0585-e063-6394a90a2224
Type
HUMAN OTC DRUG
Nonproprietary name
OCTISALATE 5%, OCTOCRYlENE 3%, ZINC OXIDE 10.5%
Dosage form
LOTION
Route
TOPICAL
Labeler
Melaleuca Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-12-27
Substance
OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
9.225; 5.535; 18.45 g/177mL; g/177mL; g/177mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sun Shades Mineral Plus Sunscreen
Brand name suffix
with Zinc Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE9.225 g/177mL
OCTOCRYLENE5.535 g/177mL
ZINC OXIDE18.45 g/177mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8886cbd0-ed2b-4a2b-a724-a0d4f12296c9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-218-062020-03-19C16284748780-19d75b9cf-f99b-f424-e053-dadaa90a57ceSun Shades Mineral Plus SPF 30+ Sunscreen
54473-218-062020-01-31C16284748780-19d75b9cf-f99b-f424-e053-dadaa90a57ceSun Shades Mineral Plus SPF 30+ Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-218-06Sun Shades Mineral Plus Sunscreenwith Zinc Oxide177 mL in 1 TUBELOTION1778

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTISALATEACTIVE INGREDIENT4X49Y0596WSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
OCTISALATEACTIVE MOIETY4X49Y0596WSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
BIXA ORELLANA SEEDINACTIVE INGREDIENTO87354RZ5ASUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
CETETH-10 PHOSPHATEINACTIVE INGREDIENT4E05O5N49GSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUASUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
DIHEXADECYL PHOSPHATEINACTIVE INGREDIENT2V6E5WN99NSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATESINACTIVE INGREDIENT0K5Y9U1P6MSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
HYDROGENATED PALM GLYCERIDESINACTIVE INGREDIENTYCZ8EM144QSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
ISOEICOSANEINACTIVE INGREDIENTAR294KAG3TSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062SUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
KUKUI NUT OILINACTIVE INGREDIENTTP11QR7B8RSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
MACADAMIA OILINACTIVE INGREDIENT515610SU8CSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
NEOPENTYL GLYCOL DIHEPTANOATEINACTIVE INGREDIENT5LKW3C543XSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
SHEANUT OILINACTIVE INGREDIENTO88E196QRFSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
SUCROSE DISTEARATEINACTIVE INGREDIENT33X4X4B90SSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8SUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VSUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-218SUN SHADES MINERAL PLUS SUNSCREEN WITH ZINC OXIDE (OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%) LOTION [MELALEUCA INC.]7Current NDC, Legacy NDC, 1 package rows20240918_8886cbd0-ed2b-4a2b-a724-a0d4f12296c9.zip

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 5 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC5990fe66-4fa2-06aa-e063-6294a90a52612026-08-21WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC5991466a-e729-16b7-e063-6394a90a11ff2026-08-21WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC597b78df-83cb-1b21-e063-6294a90a56a82026-08-20Warnings, Adverse reactionsExact identifier
application number: M020
Sunski Base Camp Face and Body Sunscreen SPF 45HOMOSALATE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLC2fc45f85-a6f8-4893-8b34-4db5e39cb6152026-08-20WarningsExact identifier
application number: M020
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Concierge Choice LLC5980055b-493e-4763-e063-6294a90a570f2026-08-20WarningsExact identifier
application number: M020
Lip Balm SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENESkin Script, LLC20c5fde7-ee8f-4b74-e063-6394a90a93ec2026-08-19WarningsExact identifier
application number: M020
Aloe UP .5OZ SPF 50 MINERAL SunscreenZINC OXIDE 14.69%Aloe Care International, LLC6ad80af3-78cd-4211-a5f2-68531aae264a2026-08-19WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsExact identifier
application number: M020
Mineral sunscreenMINERAL SUNSCREENGuangzhou Origin Beauty Cosmetics Co., Ltd.59713657-a7ef-1aee-e063-6394a90a326e2026-08-19WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 14.69%The Naked Beef820a9be-c94d-4fd5-b202-2dda5746a82a2026-08-18WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 20%The Naked Bee7dd2b1cd-e229-4eeb-8122-46fde5af10912026-08-18WarningsExact identifier
application number: M020
Sun Zapper - Baby pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee52faa-64a8-4bdf-e063-6294a90a65cf2026-08-17WarningsExact identifier
application number: M020
Sun Zapper - Face pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee4feb3-6966-67f9-e063-6394a90a16d52026-08-17WarningsExact identifier
application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
application number: M020
Soleil Defense SunscreenBROAD SPECTRUM SPF 30AMARA MED SPA LLC594244b1-db3b-002b-e063-6394a90a03292026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
application number: M020
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Charleston Dermatology, P.C.59440f7f-4213-6e2b-e063-6394a90af4832026-08-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-218-0654473021806177 mL in 1 TUBE (54473-218-06) 177 ml2018-01-010000-00-00NoNoCurrent