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Name:All Natural Sunscreen Spf 40
Manufacturer:Sarati International, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


ALL NATURAL SUNSCREEN SPF 40  - zinc oxide cream 
Sarati International, Inc.

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.

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ACTIVE INGREDIENT

ZINC OXIDE 17.5%

PURPOSE

SUNSCREEN

INACTIVE INGREDIENTS

GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, BEESWAX, SHEA BUTTER, CUPUACU (THEOBROMA GRANDIFLORUM) BUTTER, DEIONIZED WATER, OLIVE OIL, COCONUT OIL, COCOA BUTTER, JOJOBA OIL, ALOE BARBADENSIS LEAF JUICE, LEMON OIL, ORANGE OIL, p-ANISIC ACID

USES

HELPS PREVENT SUNBURN, HIGHER SPF GIVES MORE SUNBURN PROTECTION, PROVIDES HIGHER PROTECTION AGAINST SUNBURN

WHEN USING THIS PRODUCT

APPLY GENEROUSLY AND EVENLY BEFORE SUN EXPOSURE AS NEEDED, REAPPLY AS NEEDED OR AFTER SWIMMING, PERSPIRING OR TOWEL DRYING, CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

WARNINGS

FOR EXTERNAL USE ONLY, STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS, WHEN USING THIS PRODUCT KEEP OUT OF EYES, RINSE WITH WATER TO REMOVE

ALL NATURAL SUNSCREEN SPF 40

ALL NATURAL SUNSCREEN SPF 40 SAFE UV SHIELD FOR ACTIVE LIFESTYLES BROAD SPECTRUM PROTECTION FOR THE ENTIRE FAMILY FOR FACE AND BODY EFFECTIVELY IMMEDIATELY WATER RESISTANT 100% CHEMICAL FREE CRUETLY FREE BIODEGRADABLE

TRUE NATURAL COSMETICS USDA CERTIFIED BIOBASED PRODUCT PRODUCT 100% NET WT 3 OZ (84 g) MEETS TSA CARRY-ON REQUIREMENTS MADE WITH RECYCLED MILK CONTAINERS QUESTIONS CALL 877-515-TRUE OR VISIT WWW.TRUENATURALCOSMETICS.COM MADE IN THE USA MANUFACTURED FOR TRUE NATURAL COSMETICS 101 10TH STREET S. 103 KIRKLAND, WA 98033

OUR MISSION IS TO PROVIDE YOU WITH HIGH PERFORMANCE, CHEMICAL FREE PERSONAL CARE PRODUCTS THAT ARE SAFE FOR YOU, YOUR FAMILY AND THE ENVIRONMENT. ALL TRUE NATURAL COSMETIC PRODUCTS ARE FORMULATED AND PRODUCED IN THE U.S. USING 100% NATURAL INGREDIENTS. OUR INGREDIENTS AND PACKAGING ARE SUSTAINABLE AND WE ARE COMMITTED TO CERTIFIED ORGANIC INGREDIENTS WHENEVER AVAILABLE. ULI JACOB, FOUNDER

SPF 40 LABEL


ALL NATURAL SUNSCREEN SPF 40 
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67676-301
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 17.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF  
YELLOW WAX  
MEDIUM-CHAIN TRIGLYCERIDES  
COCOA BUTTER  
COCONUT OIL  
GUAZUMA ULMIFOLIA LEAF  
WATER  
GLYCERIN  
JOJOBA OIL  
LEMON OIL  
OLIVE OIL  
ORANGE OIL  
P-ANISIC ACID  
SHEA BUTTER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67676-301-01 84 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/01/1993

Labeler - Sarati International, Inc. (160219770)
Registrant - Sarati International, Inc. (160219770)
Establishment
Name Address ID/FEI Operations
Sarati International, Inc. 160219770 manufacture

Revised: 04/2011 Sarati International, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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