Raw Elements Baby Kids Broad Spectrum SPF30 Sunscreen: Package Insert and Label Information

RAW ELEMENTS BABY KIDS BROAD SPECTRUM SPF30 SUNSCREEN- zinc oxide stick
Raw Elements LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients

Non-Nano Zinc Oxide 25%

Purpose

Sunscreen

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

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 product is swallowed, get medical help or contact a Poison Control Center right away.

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
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive ingredients

Organic Helianthus Annuus (Sunflower) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Cera Flava, Organic Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed wax, Calendula Officinalis Flower Extract, Organic Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol

Other information

  • protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-442-6676

Package Labeling:

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RAW ELEMENTS BABY KIDS BROAD SPECTRUM SPF30 SUNSCREEN
zinc oxide stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70680-306
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 250 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SUNFLOWER OIL
COCOA BUTTER
COCONUT OIL
HELIANTHUS ANNUUS SEED WAX
CALENDULA OFFICINALIS FLOWER
MATRICARIA CHAMOMILLA
ROSEMARY
TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70680-306-00 1 APPLICATOR in 1 BOX contains a APPLICATOR
1 29 g in 1 APPLICATOR This package is contained within the BOX (70680-306-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/15/2019
Labeler — Raw Elements LLC (023973143)

Revised: 06/2019 Raw Elements LLC

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