Label at a glance#

ProductOZNATURALS SUNSCREEN

Active ingredientTITANIUM DIOXIDE, ZINC OXIDE

Label structure10 sections

Indications and 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.

Dosage and administration

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 ...

Label contents#

Full prescribing information#

PURPOSE

OTC - PURPOSE SECTION

POWDER SUNSCREEN

BROAD SPECTRUM SPF30

Uses

INDICATIONS & USAGE SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide : 29.3%

Zinc Oxide : 14.5%

PURPOSE: SUNSCREEN

WARNINGS:

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

• Mica

• Triethoxycaprylylsilane

• Yellow Iron Oxides

•Red Iron Oxides

• Black Iron Oxides

Distributed by OZNaturals®

HOW SUPPLIED SECTION

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?

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OZNATURALS

BROAD SPECTRUM SPF 30

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

Box

Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75592-301-01	2022-07-29	C162847	48780-1	e4f33bdf-b0ea-d8a0-e053-dadaa90a6e4e	OZNATURALS POWDER SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75592-301-01	OZNATURALS SUNSCREEN	19 g in 1 BOX	POWDER	19		4
75592-301-01	OZNATURALS SUNSCREEN	1 in 1 CARTON	POWDER	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75592-301	OZNATURALS SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER [OZ NATURALS LLC]	4	Legacy NDC, 2 package rows	20211207_a5af36be-4748-b37a-e053-2995a90a9716.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

OZNATURALS SUNSCREEN
Titanium Dioxide and Zinc Oxide
FERROSOFERRIC OXIDE
MICA
FERRIC OXIDE RED
TRIETHOXYCAPRYLYLSILANE
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
75592-301	75592-301-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FERROSOFERRIC OXIDE	XM0M87F357	IACT
MICA	V8A1AW0880	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d27cb339-7fe2-6a9a-e053-2995a90a439d			a5af36be-4748-b37a-e053-2995a90a9716	2021-12-06	Warnings	Exact identifier spl id: d27cb339-7fe2-6a9a-e053-2995a90a439d spl set id: a5af36be-4748-b37a-e053-2995a90a9716

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.