Drug Facts

Active Ingredient

Titanium Dioxide (6.00%)

Zinc Oxide (6.00%)

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

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 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:

Apply liberally 15-minutes before sun exposure.
Reapply:

- At least every two-hours. - Immediately after swimming, sweating or towel drying. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this riks, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Limit time in the sun, especially between 10am and 2pm. - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, cansult a physician.

SUN PROTECTION MEASURES.

Other ingredients

Aloe Barbadensis (Aloe Vera) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tree) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cucurbita, Glycerin, Glyceryl Stearate, Heliathus 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:

Protect this product from excessive heat and direct sunlight.

Package Labeling:

Label

PURE HAVEN BODY SPF 30
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71355-349
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71355-349-00	90 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	07/01/2018

Labeler - Pure haven, LLC (080591039)

PURE HAVEN BODY SPF-30