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

Sunshine and Glitter by

Drug Labeling and Warnings

Sunshine and Glitter by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNSHINE AND GLITTER BROAD SPECTRUM SPF 50 GLAMINGO GLITTER SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion 
Prime Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Active Ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 5%

Homosalate 10%

Purpose

Sunscreen

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.

Warnings

For external use onl

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 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

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?

Call Sunshine & Glitter 1-888-601-0441

Crayola Sunshine & Glitter Broad Spectrum SPF 50 Sunscreen Lotion

SUNSHINE AND GLITTER  BROAD SPECTRUM SPF 50 GLAMINGO GLITTER SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0590
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.1 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48.5 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	48.5 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	97 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYLACTIDE (UNII: 459TN2L5F5)
POLYURETHANE-62 (UNII: TBK645J3J8)
POLYURETHANE-34 (55 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: II1242QJ7P)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
COCOA BUTTER (UNII: 512OYT1CRR)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM (UNII: CPD4NFA903)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)

Product Characteristics
Color	white (White with pink speckles)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0590-3	100 mL in 1 TUBE; Type 0: Not a Combination Product	12/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	12/08/2021

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0590) , manufacture(58443-0590) , label(58443-0590) , analysis(58443-0590)

Revised: 11/2022

Document Id: edc6cfad-2921-733d-e053-2995a90a7b2b

34390-5

Set id: edc6cf2d-931a-2afd-e053-2995a90a6362

Version: 1

Effective Time: 20221118