CORALSAFE BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide cream 
Elements Brands

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CoralSafe Broad Spectrum SPF30

DRUG FACTS

Active Ingredients

Titanium Dioxide (6.0%)

Zinc Oxide (6.0%)

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.

When using this product,

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash or irritation occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• Apply liberally 15 minutes before sun exposure • Reapply • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • 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: Sun Protection Measures:

• Limiting time in the sun, especially from 10 am - 2 pm. • Wearing long-sleeve shirts, pants, hats and sunglasses • Children under 6 months: Ask a doctor

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera) 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:

Protect this product from excessive heat and direct sun.

Package Labeling:

Label

CORALSAFE BROAD SPECTRUM SPF30 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71221-333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 L
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
GLYCERIN (UNII: PDC6A3C0OX)  
SOYBEAN OIL (UNII: 241ATL177A)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
MANGO (UNII: I629I3NR86)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71221-333-001 in 1 CARTON06/01/2018
13.78 L in 1 JUG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/01/2018
Labeler - Elements Brands (006166707)

Revised: 11/2023
Document Id: 09d8bb51-cbef-deeb-e063-6394a90a7a60
Set id: e6e00896-b7e5-41c6-a72b-08e600758cf5
Version: 2
Effective Time: 20231110
 
Elements Brands