Otc - Active Ingredient
Active ingredients
Titanium Dioxide 7.6%
Zinc Oxide 4.0%
Safe Harbor Natural Suncare
FDA Label NDC 42421-575
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Emilia Personal Care Inc for the product Safe Harbor Natural Suncare (NDC 42421-575). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - 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
Package Label.Principal Display Panel
Copy Of Label (Baby Kids)
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