CORAL SURE SUNSCREEN SPF 35- zinc oxide lotion 
EPONINE LABS LLC

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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EPO9 - CORAL SURE SUNSCREEN SPF35 (79811-101)

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

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.

01b LBL_EPO9_Coral Sure Sunscreen_148mL

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)

Revised: 7/2022
Document Id: e37c1169-0365-1116-e053-2a95a90aa455
Set id: db4d2f39-bdce-f1e2-e053-2a95a90a2b4a
Version: 5
Effective Time: 20220710
 
EPONINE LABS LLC