SAFE HARBOR - NATURAL SUNSCREEN - BABY AND KIDS SPF50 BROAD SPECTRUM SUNSCREEN- titanium dioxide, zinc oxide cream 
Emilia Personal Care 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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Safe Harbor Natural Suncare

Active ingredient

Titanium Dioxide 11.4%
Zinc Oxide 4.0%

Purpose

Sunscreen

Uses

Warnings

For external use only.

Do not use on

When using this product

Stop use and ask a doctor

Keep Out of Reach of Children

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

Directions

Other information

Inactive ingredients

water, cyclopentasiloxane, C12-15 alkyl benzoate, caprylic/capric triglyceride, glycerin, cetyl PEG/PPG-10/1 dimethicone, cetyl dimethicone, phenyl trimethicone, phenoxyethanol, ethylhexylglycerin, trimethoxycaprylylsilane, sodium chloride, hydrogenated castor oil, microcrystaline wax, tocopheryl acetate (vitamin E), allantoin, panthenol (pro-vitamin B5), hippophae rhamnoides oil, simmondsia chinesis (jojoba) seed oil, bisabolol, avena sativa (oat) extract, echinacea purpurea root extract, camomilla recutita (matricaria) flower extract, tilia vulgaris (linden blossom) flower extract, melissa officinalis leaf extract, aspalanthus linearis (rooibos) leaf extract

Package/Label Principal Display Panel

Safe Harbor™ Natural Suncare

Free from chemical UV filters

50 Mineral SPF Broad Spectrum Sunscreen

Baby & Kids
With Natural Moisturizing Complex

100% naturally sourced sunscreen actives

Gentle formula

Easy to apply

3 Fl. Oz (88.7 mL)

Distributed by: Emilia Personal Care.
Manufactured in Israel.
For more information visit: www.safeharborsuncare.com

UVA, UVB
With Certified Organic Ingredients
Water Resistant
Allergy Tested

ZD821 2E T1

Label

Label

SAFE HARBOR - NATURAL SUNSCREEN - BABY AND KIDS SPF50 BROAD SPECTRUM SUNSCREEN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-821
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE11.4 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TRICAPRYLIN (UNII: 6P92858988)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALLANTOIN (UNII: 344S277G0Z)  
PANTHENOL (UNII: WV9CM0O67Z)  
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
JOJOBA OIL (UNII: 724GKU717M)  
LEVOMENOL (UNII: 24WE03BX2T)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42421-821-1188.7 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/05/2014
Labeler - Emilia Personal Care Inc. (965445112)

Revised: 11/2013
Document Id: 50576262-1161-4f5b-9532-81bf1954256a
Set id: 50576262-1161-4f5b-9532-81bf1954256a
Version: 1
Effective Time: 20131119
 
Emilia Personal Care Inc.