EMILIA SAFE HARBOR NATURAL SUNCARE- titanium dioxide, zinc oxide spray

emilia SAFE HARBOR NATURAL SUNCARE by

Drug Labeling and Warnings

emilia 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, 8.0%

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. If

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

Danger: Flammable. Contents under pressure. do not use near fire, heat or while

smoking. do not puncture or incincerate. store at room temperature below 120°F (48°C). use

only as directed. Intentional misuse by deliberately concentrating and inhaling the

contents can be harmful or fatal.

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  shake well, hold upright to dispense  apply liberally 15 minutes

before sun exposure  reapply at least every 2 hours  use water resistant sunscreen if

swimming or sweating  children under 6 months of age:  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 shorts, 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

cyclopentasiloxane, propane, butane, isobutane, tapioca

starch, coco-caprylate/caprate, fragrance,

trimethoxycaprylylsilane, polyglycerol-3 polyricinoleate,

isostearic acid, bisabolol, tocopheryl acetate (vitamin E),

simmondsia chinensis (jojoba) seed oil, vitis vinifera (grape)

seed oil, helianthus annuus (sunflower) seed oil, ricinus

communis (castor) oil, sesamum indicum (sesame) seed oil.

PRINCIPAL DISPLAY PANEL

emilia

SAFE HARBOR NATURAL SUNCARE

NATURAL

SUNSCREEN SPRAY

NON-NANO ZINCLEAR

INGREDIENTS AND APPEARANCE

EMILIA SAFE HARBOR NATURAL SUNCARE 
titanium dioxide, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42421-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.92 g  in 150 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	11.50 g  in 150 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANE (UNII: T75W9911L6)
BUTANE (UNII: 6LV4FOR43R)
ISOBUTANE (UNII: BXR49TP611)
STARCH, TAPIOCA (UNII: 24SC3U704I)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
ISOSTEARIC ACID (UNII: X33R8U0062)
LEVOMENOL (UNII: 24WE03BX2T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
GRAPE SEED OIL (UNII: 930MLC8XGG)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
SESAME OIL (UNII: QX10HYY4QV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42421-200-01	150 g in 1 PACKAGE; Type 0: Not a Combination Product	12/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/07/2017

Labeler - Emilia Personal Care Inc (965445112)