Label: CORAL SURE SUNSCREEN SPF 35- zinc oxide lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 79811-101-11, 79811-101-13, 79811-101-15 - Packager: EPONINE LABS LLC
- Category: HUMAN OTC DRUG LABEL
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
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
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?
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CORAL SURE SUNSCREEN SPF 35
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79811-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25.2 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:79811-101-15 148 mL in 1 TUBE; Type 0: Not a Combination Product 03/28/2022 2 NDC:79811-101-11 29 mL in 1 POUCH; Type 0: Not a Combination Product 03/28/2022 3 NDC:79811-101-13 88 mL in 1 TUBE; Type 0: Not a Combination Product 03/28/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/28/2022 Labeler - EPONINE LABS LLC (118722079)