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

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 Identifiers#

Field, Values table
FieldValues
Unii4X49Y0596W, 5A68WGF6WM, SOI2LOH54Z

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

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