FDA.reportPublic FDA data

Sunshine and Glitter

Manufacturer
Prime Enterprises Inc.
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:16:14

Label at a glance#

ProductSunshine and Glitter Broad Spectrum SPF 50 Glamingo Glitter Sunscreen
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE
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 reapply: after 40 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 skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, es...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 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 - ASK DOCTOR 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 40 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 skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aluminum, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Phenoxyethanol, Polybutylene Terephthalate, Polyethylene , Polylactic Acid, Polysorbate 20, Polyurethane, Polyurethane-33, Propylene Glycol, Red 7, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-601-0441

Sunshine & Glitter Sea Star Sparkle Glamingo Glitter Sunscreen Lotion Broad Spectrum SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-051958443-0519-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYLACTIDE459TN2L5F5IACT
POLYURETHANE-62TBK645J3J8IACT
POLYURETHANE-34 (55 MPA, TENSILE STRENGTH OF FILM AT BREAK)II1242QJ7PIACT
D&C RED NO. 7ECW0LZ41X8IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
COCOA BUTTER512OYT1CRRIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM HYDROXIDE55X04QC32IIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALUMINUMCPD4NFA903IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT

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
d5cd6565-27ff-4836-e053-2995a90a785fd5cd7a90-7616-4303-e053-2995a90aef742022-01-17WarningsExact identifier
spl id: d5cd6565-27ff-4836-e053-2995a90a785f
spl set id: d5cd7a90-7616-4303-e053-2995a90aef74

Reported adverse events (FAERS/openFDA)#

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