Label: CORAL SURE SUNSCREEN SPF 35- zinc oxide lotion

  • 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 July 10, 2022

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  • ACTIVE INGREDIENTS

    Zinc Oxide 25.2%

  • 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 only
    • do not use on damaged or broken skin
    • stop use and ask a doctor if rash occurs
    • when using this product, keep out of eyes. Rinse with water to remove
  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    • Apply liberally 15 minutes before sun exposure • Reapply: • After 40 minutes of swimming or sweating • Immediately
    after towel drying • At least every 2 hours • Children under 6 months: ask a doctor.

    Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk the CDC recommends regular use of sunscreen with a broad spectrum SPF value of 15 or higher, with both UVA and UVB (broad spectrum) protection, and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

  • INACTIVE INGREDIENT

    Water, Caprylic/Capric Triglyceride, C13-15 Alkane, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 olyricinoleate, Capryloyl Glycerin/Sebacic Acid Copolymer, Ethylcellulose, Butyloctyl Salicylate, Sorbitol, Erythritol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Behenate, Glyceryl Caprylate, Polyglyceryl-10 Mono/Dioleate, Pentylene Glycol, C13-C14 Alkane, C15-C23 Alkane, Glycerin, Decyl Glucoside, Vitis Vinifera (Grape) Seed Oil, Magnolia Officinalis Bark Extract, Fragrance, Oryza Sativa (Rice) Bran Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol (Vitamin E), Rosmarinus Officinalis (Rosemary) Leaf Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Sodium Hyaluronate, Bisabolol, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Diisopropyl Sebacate, Lauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Adipate

  • QUESTIONS? COMMENTS?

    Contact us at: Eponine Corp., PO Box 642111, Los Angeles, CA 90064. • Manufactured for and distributed by Eponine Corporation.
    • To learn more please visit us at: www.epo9coralsure.com.

  • OTHER INFORMATION

    • protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_EPO9_Coral Sure Sunscreen_148mL

  • INGREDIENTS AND APPEARANCE
    CORAL SURE SUNSCREEN  SPF 35
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79811-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    RICE BRAN (UNII: R60QEP13IC)  
    C15-23 ALKANE (UNII: J3N6X3YK96)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    ROSEMARY (UNII: IJ67X351P9)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SORBITOL (UNII: 506T60A25R)  
    ERYTHRITOL (UNII: RA96B954X6)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79811-101-15148 mL in 1 TUBE; Type 0: Not a Combination Product03/28/2022
    2NDC:79811-101-1129 mL in 1 POUCH; Type 0: Not a Combination Product03/28/2022
    3NDC:79811-101-1388 mL in 1 TUBE; Type 0: Not a Combination Product03/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/28/2022
    Labeler - EPONINE LABS LLC (118722079)
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