Label: OZNATURALS SUNSCREEN- titanium dioxide and zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 75592-301-01 - Packager: OZ Naturals LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 6, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- Uses
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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
- WARNINGS:
- Warnings
- INACTIVE INGREDIENTS:
- Distributed by OZNaturals®
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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
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INGREDIENTS AND APPEARANCE
OZNATURALS SUNSCREEN
titanium dioxide and zinc oxide powderProduct 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)
