Emilia Safe Harbor Spray

Manufacturer
Emilia Personal Care Inc
Effective date
2021-11-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:29:27

Label at a glance#

Productemilia SAFE HARBOR NATURAL SUNCARE
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Storage and handling

Other information   protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Titanium Dioxide, 7.6%

Zinc Oxide, 8.0%

OTC - PURPOSE SECTION

Purpose

Sunscreen

Sunscreen

INDICATIONS & USAGE SECTION

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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children. If

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other information  protect the product in this container from

excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

emilia

SAFE HARBOR NATURAL SUNCARE

NATURAL

SUNSCREEN SPRAY

NON-NANO ZINCLEAR

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42421-20042421-200-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fe52b3ad-4ea1-3880-e053-6294a90ac097fc1edc60-6d48-4570-8c56-be38366413892023-06-17WarningsExact identifier
spl set id: fc1edc60-6d48-4570-8c56-be3836641389

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.