Safe Harbor - Natural Sunscreen - Baby and Kids SPF50 Broad Spectrum Sunscreen description, usages, side effects, indications, overdosage, supplying and lots more!

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Safe Harbor - Natural Sunscreen - Baby and Kids SPF50 Broad Spectrum Sunscreen

Emilia Personal Care Inc.

Safe Harbor Natural Suncare


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Titanium Dioxide 11.4%
Zinc Oxide 4.0%

Purpose

Sunscreen

Safe Harbor - Natural Sunscreen - Baby and Kids SPF50 Broad Spectrum 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.

  • 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

Safe Harbor - Natural Sunscreen - Baby and Kids SPF50 Broad Spectrum Sunscreen 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

Package/Label Principal Display Panel

Safe Harbor™ Natural Suncare

Free from chemical UV filters

50 Mineral SPF Broad Spectrum Sunscreen

Baby & Kids
With Natural Moisturizing Complex

100% naturally sourced sunscreen actives

Gentle formula

Easy to apply

3 Fl. Oz (88.7 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

ZD821 2E T1

Safe Harbor - Natural Sunscreen - Baby and Kids SPF50 Broad Spectrum Sunscreen
Label

Safe Harbor - Natural Sunscreen - Baby and Kids SPF50 Broad Spectrum Sunscreen

Titanium Dioxide, Zinc Oxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42421-821
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 11.4 g
Zinc Oxide Zinc oxide 4 g

Inactive Ingredients

Ingredient Name Strength
water
CYCLOMETHICONE 5
ALKYL (C12-15) BENZOATE
TRICAPRYLIN
GLYCERIN
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
CETYL DIMETHICONE 150
PHENYL TRIMETHICONE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
TRIMETHOXYCAPRYLYLSILANE
SODIUM CHLORIDE
HYDROGENATED CASTOR OIL
MICROCRYSTALLINE WAX
.ALPHA.-TOCOPHEROL ACETATE
ALLANTOIN
PANTHENOL
HIPPOPHAE RHAMNOIDES FRUIT OIL
Jojoba Oil
LEVOMENOL
Oat Kernel Oil
ECHINACEA PURPUREA ROOT
MATRICARIA CHAMOMILLA FLOWERING TOP OIL
TILIA X EUROPAEA FLOWER
MELISSA OFFICINALIS LEAF
ASPALATHUS LINEARIS LEAF

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42421-821-11 88.7 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-01-05


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