Safe Harbor Natural Suncare

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 22:29:26

Label at a glance#

ProductSafe Harbor Natural Suncare Natural Face and Neck Broad Spectrum
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  7.1%

Zinc Oxide  3.5%

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

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  -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 SECTION

Other information  protect the product in this container from

excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive ingredients water, caprylic/capric triglyceride,

sesamum indicum (sesame) seed oil, helianthus annuus (sunflower) seed

oil, glycerin, coco-glucoside, coconut alcohol,

 ricinus communis (castor) oil, simmondsia chinensis

 (jojoba) seed oil, butyrospermum parkii (shea)

 butter, microcrystalline cellulose, cellulose gum,

 arachidyl alcohol, behenyl alcohol, arachidyl

 glucoside, phenoxyethanol, ethylhexylglycerin,

 xanthan gum, PEG-40 stearate, trimethoxycaprylylsilane,

 fragrance, allantoin, tocopheryl acetate

 (vitamin E), panthenol (pro-vitamin B5), lecithin, soy

 isflavones, polysorbate 80, hippophae rhamnoides

 oil, bisabolol, chamomilla recutita (matricaria)flower

 extract, tilia vulgaris _ower extract, Melissa

 officinalis leaf extract, aspalathus linearis leaf

 extract, sodium lactate, porphyra umbilicalis extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42421-07642421-076-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Source Document#

Source XML · Source PDF

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
016634a2-a6c2-286d-e063-6394a90a90b6df6b976c-c8d4-48e3-8d11-489c408e10f62023-07-26WarningsExact identifier
spl set id: df6b976c-c8d4-48e3-8d11-489c408e10f6

Reported adverse events (FAERS/openFDA)#

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