CORAL SURE SUNSCREEN

Manufacturer
EPONINE LABS LLC
Effective date
2022-07-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:50:07

Label at a glance#

ProductCORAL SURE SUNSCREEN SPF 35
Active ingredientZINC OXIDE
Label structure10 sections

Indications and 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.

Dosage and administration

• 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 h...

Storage and handling

• protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25.2%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

STORAGE AND HANDLING SECTION

• protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_EPO9_Coral Sure Sunscreen_148mL01b LBL_EPO9_Coral Sure Sunscreen_148mL

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79811-101-11CORAL SURE SUNSCREENSPF 3529 mL in 1 POUCHLOTION295
79811-101-13CORAL SURE SUNSCREENSPF 3588 mL in 1 TUBELOTION885
79811-101-15CORAL SURE SUNSCREENSPF 35148 mL in 1 TUBELOTION1485

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79811-101CORAL SURE SUNSCREEN SPF 35 (ZINC OXIDE) LOTION [EPONINE LABS LLC]5Legacy NDC, 3 package rows20220712_db4d2f39-bdce-f1e2-e053-2a95a90a2b4a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79811-10179811-101-15, 79811-101-11, 79811-101-13

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e37c1169-0365-1116-e053-2a95a90aa455db4d2f39-bdce-f1e2-e053-2a95a90a2b4a2022-07-10WarningsExact identifier
spl id: e37c1169-0365-1116-e053-2a95a90aa455
spl set id: db4d2f39-bdce-f1e2-e053-2a95a90a2b4a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.