PURE HAVEN FACE SUNSCREEN SPF-30- zinc oxide lotion

PURE HAVEN Face Sunscreen SPF-30 by

Drug Labeling and Warnings

PURE HAVEN Face Sunscreen SPF-30 by is a Otc medication manufactured, distributed, or labeled by Pure Haven, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide (14%)

Purpose

sunscreen

Uses:

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.
• 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 develops and lasts.

Keep out of reach of children.

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

Directions:

• Apply liberally 15 minutes before sun exposure. 
• Children under 6 months of age: ask a doctor.
• Reapply at least every 2 hours.
• Reapply as needed or after towel drying, swimming, or sweating.
• Use a water-resistant sunscreen if swimming or sweating.

• Limit time in the sun, especially from 10 a.m. - 2 p.m. 
• Wear long-sleeved shirts, pants, hats and sunglasses.

SUN PROTECTION MEASURES.

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

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Citric Acid, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydrolyzed Jojoba Esters, Lecithin, Polyhydroxystearic Acid, Tocopherol (Vitamin E),Tridecyl Salicylate, Xanthan Gum.

Other Information:

• Protect the product in this container from excessive heat and direct sun.

Package Labeling:

INGREDIENTS AND APPEARANCE

PURE HAVEN FACE SUNSCREEN SPF-30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71355-219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	140 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71355-219-00	30 mL in 1 JAR; Type 0: Not a Combination Product	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2021

Labeler - Pure Haven, LLC (080591039)