FDA.reportPublic FDA data

Coral Safe Broad Spectrum SPF-30 Cream

Manufacturer
Elements Brands Inc.
Effective date
2017-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:20:20

Label at a glance#

ProductCoral Safe Broad Spectrum SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 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 80 minutes of swimming or sweating  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: Limiting time in the...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (6.0%)

Zinc Oxide (6.0%)

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 

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product.

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash or irritation occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is 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 80 minutes of swimming or sweating 
  • 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:
  • Limiting time in the sun, especially from 10 am- 2pm.
  • Wearing long-sleeve shirs, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Dehydroxanthan Gum, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Mangifera Indica (Mango) Butter, Sodium Benzoate, Sodium Laurylglucosides Hydroxypropylsulfonate, Styrene/Acrylates Copolymer, Tocopheryl (VItamin E), Xanthan Gum

Other Information:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoralCoral

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71221-78371221-783-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
COCONUT OILQ9L0O73W7LIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
DEHYDROXANTHAN GUM63ZP7I1BQOIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
SOYBEAN OIL241ATL177AIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
MANGOI629I3NR86IACT
SODIUM BENZOATEOJ245FE5EUIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
XANTHAN GUMTTV12P4NEEIACT

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
071ae821-9cdb-397c-e063-6394a90a11c2477b067c-e482-4110-e054-00144ff8d46c2023-10-07WarningsExact identifier
spl set id: 477b067c-e482-4110-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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