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

Safe Harbor Natural Suncare by

Drug Labeling and Warnings

Safe Harbor Natural Suncare by is a Otc medication manufactured, distributed, or labeled by Emilia Personal Care Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Titanium Dioxide  7.6%

Zinc Oxide  4.0%

PURPOSE

Purpose

Sunscreen

Sunscreen

INDICATIONS & USAGE

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

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

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Other information  protect the product in this container from

excessive heat and direct sun

INACTIVE INGREDIENT

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, sodium lactate, porphyra umbilicalis extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42421-875
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9.4 g  in 124 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.96 g  in 124 g

Inactive Ingredients
Ingredient Name	Strength
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)
SODIUM LACTATE (UNII: TU7HW0W0QT)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42421-875-15	124 g in 1 TUBE; 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	11/15/2015

Labeler - Emilia Personal Care Inc (965445112)