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 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 1 of 360 · 7,197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-06WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC58636012-7e29-7206-e063-6394a90a83e92026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-06WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864275d-a480-06f8-e063-6394a90aecab2026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864881c-c495-1f32-e063-6294a90a13042026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Elta MD UV Daily Peptide Lip Balm SPF 40ZINC OXIDECP Skin Health Group, Inc945538b5-5745-42cf-b610-0018ca2ec2542026-08-06WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC58653d79-8fff-f319-e063-6294a90af7a32026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5865f0e5-14b2-c4bf-e063-6294a90a47102026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
application number: M020
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC129ae274-0094-be5e-e063-6394a90a98012026-08-05WarningsExact identifier
application number: M020
HERA UV PROTECTOR INVISIBLE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOTCM584c371c-24e3-5f9c-e063-6294a90a01bc2026-08-05WarningsExact identifier
application number: M020
Leader Kids Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER3636693a-ba81-5d49-e063-6394a90a30062026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 IvoryCEILE TINT PROTECT TINTED SERUM SPF 50 IVORYLE COSMETICS INC58547809-3480-1032-e063-6294a90a04c62026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium DeepCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEPLE COSMETICS INC58549160-3594-9056-e063-6394a90abf7d2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 DeepCEILE TINT PROTECT TINTED SERUM SPF 50 DEEPLE COSMETICS INC585498d4-b29c-9580-e063-6394a90adf1e2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 FairCEILE TINT PROTECT TINTED SERUM SPF 50 FAIRLE COSMETICS INC58545633-cb36-6611-e063-6394a90a1f072026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 LightCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHTLE COSMETICS INC5853ae6b-0eaf-e614-e063-6394a90ae91a2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light MediumCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUMLE COSMETICS INC585473c3-3ee9-7d84-e063-6394a90abd332026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 MediumCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUMLE COSMETICS INC58547b48-251a-10eb-e063-6294a90ac95c2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium TanCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TANLE COSMETICS INC58547e38-ae84-82ee-e063-6394a90a27d62026-08-05WarningsExact 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