Label: SHAMROCK SUN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 58443-0522-7
- Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 17, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- PURPOSE
- Uses
- Warnings
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Directions
- shake well before use
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decease this risk, regularly use a sunscreen with a 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
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Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water
- Other information
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INGREDIENTS AND APPEARANCE
SHAMROCK SUN SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0522 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.04 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 96.8 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 48.4 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 48.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYSORBATE 20 (UNII: 7T1F30V5YH) COCOA BUTTER (UNII: 512OYT1CRR) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HYPROMELLOSES (UNII: 3NXW29V3WO) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0522-7 964 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/12/2019 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0522) , pack(58443-0522) , manufacture(58443-0522) , analysis(58443-0522)