Label: CORETEX BROAD SPECTRUM SPF 30 SUNSCREEN- octisalate, avobenzone, homosalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0420-1 - 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 September 10, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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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 a broad spectrum SPF value 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 of age: Ask a doctor
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INACTIVE INGREDIENTS
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Ethylhexylglycerin, Isodecyl Neopentanoate, Isopropylphthalimide, PEG-8, Phenoxyethanol, Polyethylene, Polysorbate 20, Propanediol, Sodium Hydroxide, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Water
- Other Information
- Questions or Comments?
- ALOE UP SPORT PERFORMANCE SUNSCREEN LOTION Broad spectrum SPF 50 - 89 mL
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INGREDIENTS AND APPEARANCE
CORETEX BROAD SPECTRUM SPF 30 SUNSCREEN
octisalate, avobenzone, homosalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0420 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 73.5 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 49 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.4 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49 mg in 1 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) COCOA BUTTER (UNII: 512OYT1CRR) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HYPROMELLOSES (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white (Off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0420-1 18927 mL in 1 CONTAINER; Type 0: Not a Combination Product 12/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/21/2020 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0420) , manufacture(58443-0420) , label(58443-0420) , analysis(58443-0420)