OZNATURALS SUNSCREEN- titanium dioxide and zinc oxide powder

OZNATURALS SUNSCREEN by

Drug Labeling and Warnings

OZNATURALS SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by OZ Naturals LLC, OZ NATURALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

POWDER SUNSCREEN

BROAD SPECTRUM SPF30

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.

DIRECTIONS FOR USE:

AFTER APPLICATION OF YOUR DAILY OZNATURALS SKINCARE REGIMEN AND MAKEUP (IF APPLICABLE), OPEN LID AND MAKE SURE THE SIFTER INSIDE IS OPEN, THEN PUT LID BACK ON AND SHAKE WELL. NEXT, LIGHTLY DIP YOUR MAKEUP BRUSH ONTO THE TOP OF SUNSCREEN POWDER, TAPPING THE BRUSH ON THE SIDE OF CONTAINER TO REMOVE EXCESS AMOUNT OF POWDER. USING CIRCULAR SWIRLS, APPLY SUNSCREEN POWDER TO ENTIRE FACE, NECK, AND DÉCOLLETÉ. SINCE THIS POWDER GIVES A PEARLESCENT HUE TO THE SKIN, YOU MAY APPLY A BRONZER BEFOREHAND TO ADD MORE COLOR TO THE SKIN IF NECESSARY.

APPLY LIBERALLY AND EVENLY 15 MINUTES BEFORE SUN EXPOSURE. 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 VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMITING TIME IN THE SUN, ESPECIALLY FROM 10AM-2PM, WEARING LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES. REAPPLY AT LEAST EVERY 2 HOURS.

USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.

CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

ACTIVE INGREDIENT

Titanium Dioxide : 29.3%

Zinc Oxide : 14.5%

PURPOSE: SUNSCREEN

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 occurs.

Keep out of reach of children

If product is swallowed seek medical help or contact Poison Control immediately.

Warnings

Keep out of reach of children

INACTIVE INGREDIENTS:

Mica

Triethoxycaprylylsilane

Yellow Iron Oxides

Red Iron Oxides

Black Iron Oxides

Distributed by OZNaturals®

319 Clematis St. Ste. 700,
West Palm Beach, FL 33401

Unit 3, Lake Farm House
Allington Lane, Fair Oak, Eastleigh
Hampshire SO50 7DD United Kingdom

MADE IN CANADA

WHAT IS COLD PROCESSED SKINCARE?

OZNATURALS’ UNIQUE COLD PROCESSING TAKES PLACE AT ROOM TEMPERATURE WITHOUT ANY DAMAGING HEAT OR PETROCHEMICALS. THIS ALLOWS OUR QUALITY INGREDIENTS TO REMAIN HIGHLY POTENT AND EFFECTIVE, SINCE HEAT DESTROYS ACTIVE INGREDIENTS. THIS ENSURES THE BEST BENEFITS FOR YOUR SKIN.

PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

Principal Display Panel

OZNATURALS

BROAD SPECTRUM SPF 30

POWDER SUNSCREEN
19g / 1 OZ. US.
97% NATURAL

INGREDIENTS AND APPEARANCE

OZNATURALS SUNSCREEN 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75592-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	293 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	145 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75592-301-01	1 in 1 CARTON	06/30/2020
1		19 g in 1 BOX; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/30/2020

Labeler - OZ Naturals LLC (079726946)

Registrant - OZ Naturals LLC (079726946)

Establishment
Name	Address	ID/FEI	Business Operations
OZ NATURALS LLC		079726946	manufacture(75592-301) , pack(75592-301) , label(75592-301)