Active Ingredient
Titanium Dioxide 10.4%
Zinc Oxide 4.0%
Safe Harbor - Natural - Sensitive Spf50 Broad Spectrum
FDA Label NDC 42421-926
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 - Sensitive Spf50 Broad Spectrum (NDC 42421-926). 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 active ingredient, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
- helps prevent sunburn
- If used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
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.
Directions
- 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: ask a doctor
- Sun Protection Measures: Spending time in the sun increases your risk of sun 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 10a.m. - 2p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
- protect the product in this container from excessive heat and direct sun
Inactive Ingredients
water, cyclopentasiloxane, C12-15 alkyl benzoate, caprylic/capric triglyceride, glycerin, cetyl PEG/PPG-10/1 dimethicone, cetyl dimethicone, trimethoxycaprylylsilane, phenyl trimethicone, phenoxyethanol, ethylhexylglycerin, sodium chloride, hydrogenated castor oil, microcrystaline wax, tocopheryl acetate (vitamin E), allantoin, panthenol (pro-vitamin B5), lecithin, soy isoflavones, polysorbate 80, hippophae rhamnoides oil, bisabolol, camomilla recutita (matricaria) flower extract, tilia vulgaris (linden blossom) flower extract, melissa officinalis (lemon balm) leaf extract, aspalanthus linearis (rooibos) leaf extract, sodium lactate, porphyra umbilicalis extract
Package/Label Principal Display Panel
Safe Harbor™ Natural Suncare
Free from chemical UV filters
50 Mineral SPF Broad Spectrum Sunscreen
Sensitive Lotion
With Natural Anti-Aging Complex
Moisturizing sunscreen lotion
Anti-aging treatment
rich in age-defying antioxidants
4 Fl. Oz (118.3 mL)
Distributed by: Emilia Personal Care.
Manufactured in Israel.
For more information visit: www.safeharborsuncare.com
UVA, UVB
With Certified Organic Ingredients
Water Resistant
Allergy Tested
ZD926 2E T1
Label (E615176c E829 4f5c 8d46 0fb405e9c1e2 01)
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