Label: CORETEX SUN X SPF 30 NEW- avobenzone, homosalate, octisalate, octocrylene lotion
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NDC Code(s):
65753-110-01,
65753-110-02,
65753-110-03,
65753-110-04, view more65753-110-05, 65753-110-07, 65753-110-08, 65753-110-09, 65753-110-10, 65753-110-18, 65753-110-22, 65753-110-23, 65753-110-24, 65753-110-25, 65753-110-26, 65753-110-32, 65753-110-33, 65753-110-34, 65753-110-35, 65753-110-37, 65753-110-40
- Packager: CoreTex Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 30, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 sweatingchildren under 6 months of age: Ask a doctor
- 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 of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10:00 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
- children under 6 months: Ask a doctor
- Other information
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Inactive ingredients
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, C12-15 alkyl benzoate, carbomer, disodium EDTA, ethylhexylglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan, oleate, theobroma cacao (cocoa) seed butter, tocopherol acetate, water
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INGREDIENTS AND APPEARANCE
CORETEX SUN X SPF 30 NEW
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65753-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) SODIUM HYDROXIDE (UNII: 55X04QC32I) PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI) THEOBROMA CACAO WHOLE (UNII: EB048G1S9J) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYSORBATE 20 (UNII: 7T1F30V5YH) METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) PROPYLENE GLYCOL PROPYL ETHER (UNII: 92KA3PYX0S) MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65753-110-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2021 2 NDC:65753-110-32 44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2021 3 NDC:65753-110-02 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2021 4 NDC:65753-110-33 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2021 5 NDC:65753-110-03 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2021 6 NDC:65753-110-34 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2021 7 NDC:65753-110-04 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2021 8 NDC:65753-110-05 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2021 9 NDC:65753-110-07 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2021 10 NDC:65753-110-09 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2021 11 NDC:65753-110-10 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/07/2021 12 NDC:65753-110-37 44 mL in 1 PACKET; Type 0: Not a Combination Product 01/07/2021 13 NDC:65753-110-18 1000 in 1 CARTON 01/07/2021 13 44 mL in 1 PACKET; Type 0: Not a Combination Product 14 NDC:65753-110-22 25 in 1 CONTAINER 01/07/2021 14 7 mL in 1 PACKET; Type 0: Not a Combination Product 15 NDC:65753-110-23 50 in 1 CONTAINER 01/07/2021 15 7 mL in 1 PACKET; Type 0: Not a Combination Product 16 NDC:65753-110-24 50 in 1 CARTON 01/07/2021 16 7 mL in 1 PACKET; Type 0: Not a Combination Product 17 NDC:65753-110-25 100 in 1 CARTON 01/07/2021 17 7 mL in 1 PACKET; Type 0: Not a Combination Product 18 NDC:65753-110-26 300 in 1 BOX 01/07/2021 18 7 mL in 1 PACKET; Type 0: Not a Combination Product 19 NDC:65753-110-08 1 in 1 BOX 01/07/2021 19 500 mL in 1 BAG; Type 0: Not a Combination Product 20 NDC:65753-110-40 1 in 1 BOX 01/07/2021 11/21/2022 20 751 mL in 1 BOTTLE; Type 0: Not a Combination Product 21 NDC:65753-110-35 751 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/07/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/07/2021 Labeler - CoreTex Products Inc (061944620) Establishment Name Address ID/FEI Business Operations CoreTex Products Inc 061944620 pack(65753-110) Establishment Name Address ID/FEI Business Operations Prime Enterprises 101946028 manufacture(65753-110)
