SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM- titanium dioxide, zinc oxide lotion 
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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Drug Facts

Titanium Dioxide  7.6%

Zinc Oxide  4.0%

Purpose

Sunscreen


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.

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 swallowed, get medical help or

contact a Poison Control Center right away.

Directions  -Apply liberally 15 minutes before sun exposure.

-Reapply  -After 80 minutes of swimming or sweating

-immediately after towel drying  -At least every 2 hours; Children

under 6 months: Ask a doctor.  -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:

-Limit time in the sun, especially from 10 a.m. - 2 p.m.   -Wear long-

sleeved shirts, pants, hats and sunglasses.

Other information  protect the product in this container from

excessive heat and direct sun

Inactive ingredients   water, caprylic/capric triglyceride, sesamum

indicum (sesame) seed oil, helianthus annuus

(sunflower) seed oil, glycerin, cetearyl alcohol,

cetearyl glucoside, simmondsia chinensis

(jojaba) seed oil, glyceryl stearate,

butyrosperum parkii (shea) butter, potassium

cetyl phosphate, phenoxyethanol, ethylhexylglycerin,

xanthan gum, PEG-40 stearate, trimethoxycaprylsilane, allantoin,

tocopherol acetate (vitamin E), panthenol (pro-vitamin B5),

bisabolol, hippophae rhamnoides oil, avena sativa (oat) kernel extract,

echinacea purpurea root extract, chamomilla recutita (matricaria) flower extract,

tilia vulgaris flower extract, melissa officinalis leaf extract,

aspalathus linearis leaf extract

copy of label

SAFE HARBOR NATURAL SUNCARE  BROAD SPECTRUM
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-575
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.4 g  in 124 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.96 g  in 124 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SESAME OIL (UNII: QX10HYY4QV)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
JOJOBA OIL (UNII: 724GKU717M)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
LEVOMENOL (UNII: 24WE03BX2T)  
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
OAT (UNII: Z6J799EAJK)  
ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
MATRICARIA RECUTITA ROOT (UNII: BTG5H50X7F)  
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:42421-575-15124 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2015
Labeler - Emilia Personal Care Inc (965445112)

Revised: 11/2015
Document Id: 457b8d97-15ee-44eb-a985-b6e69e1ad1d3
Set id: ae98d652-b2c8-4c81-a126-e054d6b8eb88
Version: 1
Effective Time: 20151120
 
Emilia Personal Care Inc