Safe Harbor - Natural Sunscreen - Baby And Kids Spf50 Broad Spectrum Sunscreen
FDA Label NDC 42421-821

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 Sunscreen - Baby And Kids Spf50 Broad Spectrum Sunscreen (NDC 42421-821). 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

→ 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

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package/label Principal Display Panel

Active Ingredient

Titanium Dioxide 11.4%
Zinc Oxide 4.0%

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, phenyl trimethicone, phenoxyethanol, ethylhexylglycerin, trimethoxycaprylylsilane, sodium chloride, hydrogenated castor oil, microcrystaline wax, tocopheryl acetate (vitamin E), allantoin, panthenol (pro-vitamin B5), hippophae rhamnoides oil, simmondsia chinesis (jojoba) seed oil, bisabolol, avena sativa (oat) extract, echinacea purpurea root extract, camomilla recutita (matricaria) flower extract, tilia vulgaris (linden blossom) flower extract, melissa officinalis leaf extract, aspalanthus linearis (rooibos) leaf extract