FDA.reportPublic FDA data

SEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton Candy

Manufacturer
MJ Products Association, LLC
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:56

Label at a glance#

ProductSEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton Candy
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDE
Label structure8 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 15 minutes before sun exposure. At least every two-hours. Immediately after swimming, sweating or towel drying. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use suncreen with broad spectrum protection and on SPF rating of 15 or higher, along with other sun protection measures including: Limit time in the sun, especially between 1...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10.00%

Octocrylene 5.00%

Octisalate 5.00%

Zinc Oxide 4.00%

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.

Do not use 

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product 

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and consult physician

OTC - STOP USE SECTION

if irritation or rash develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical attention or contact poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • At least every two-hours.
  • Immediately after swimming, sweating or towel drying. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use suncreen with broad spectrum protection and on SPF rating of 15 or higher, along with other sun protection measures including: Limit time in the sun, especially between 10am and 2pm.  SUN PROTECTION MEASURES:
  • Wear long sleeve shirts, pants, hats, and sunglasses.
  • For children under 6 months, consult a physician.

REAPPLY:

Other Ingredients

INACTIVE INGREDIENT SECTION

Acrylate Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel), Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Camellia Sinensis (Green Tea), Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Ethylhexylglycerin, Glitter: Regenerated Cellulose/Rayon, FD&C Yellow #5, D&C Red 34, Aluminium; Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Tocopherol Acetate (Vitamin E), Zemea (Corn) Propanediol.

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sunlight.

Questions or comments?

OTC - QUESTIONS SECTION

Contact us directly at 1-888-601-0441

Package Labeling: 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label8Label8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72085-308-00SEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton Candy113 g in 1 PACKETCREAM1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72085-308SEA STAR SPARKLE SPF 50 GLITTER SUNSCREEN COTTON CANDY (HOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDE) CREAM [MJ PRODUCTS ASSOCIATION, LLC]3Current NDC, Legacy NDC, 1 package rows20231106_43c84cab-e35b-4808-bcc5-399573aef3b4.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72085-30872085-308-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETEARYL OLIVATE58B69Q84JOIACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
REGENERATED CELLULOSEBX81F82EWGIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 34BAN556989EIACT
ALUMINUMCPD4NFA903IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
SORBITAN OLIVATEMDL271E3GRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CORN0N8672707OIACT
PROPANEDIOL5965N8W85TIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton CandyHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC43c84cab-e35b-4808-bcc5-399573aef3b42023-11-05WarningsExact identifier
ndc (package): 72085-308-00
ndc (product): 72085-308
ndc11 (package): 72085030800
spl id: 097478f1-9b5a-b749-e063-6394a90a9977
spl set id: 43c84cab-e35b-4808-bcc5-399573aef3b4

Reported adverse events (FAERS/openFDA)#

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