PURE HAVEN ESSENTIALS- titanium dioxide, zinc oxide cream 
Pure Haven LLC

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Pure Haven Essentials SPF-30

Drug Facts

Active Ingredient

Titanium Dioxide (6.00%) Zinc Oxide (6.00%)

Purpose

Sunscreen

Uses

Warnings:

For external use

Do not use 

on damaged or broken skin.

When using this product 

keep out of eyes. Rinse with water to remove.

Stop use and consult physician 

if irritation or rash develops. 

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

Directions:

- At least every tow-hours.

- Immediately after swimming, sweating or towel drying.

Spending time in the sun increase your risk of skin cancer and early skin aging . To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun protection measures. 

- Limit time in the sun, especially between 10am and 2pm.

- Wear long sleeve shirts, pants, hats and sunglasses.

- For childre under 6-months, consult with a physician.

Other Ingredients

Aloe Barbadensis (Aloe vera) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cucurbita Pepo (Pumpkin) Seed Oil, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Leuconostoc/Radish Root Ferment Filtrate, Prunus Amygdalus Dulcis (Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Olivate, Theobroma Cacao (Cocoa) Butter, Xanthan Gum

Other Information:

Package Labeling:

Label2

PURE HAVEN ESSENTIALS 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71355-819
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
ALMOND (UNII: 3Z252A2K9G)  
SESAME OIL (UNII: QX10HYY4QV)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
COCOA (UNII: D9108TZ9KG)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71355-819-0390 mL in 1 TUBE; Type 0: Not a Combination Product03/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/28/2017
Labeler - Pure Haven LLC (080591039)

Revised: 11/2023
Document Id: 09db5696-960c-d689-e063-6394a90aeb01
Set id: 4bccc017-266d-11ce-e054-00144ff8d46c
Version: 2
Effective Time: 20231111
 
Pure Haven LLC