RAW ELEMENTS BABY KIDS BROAD SPECTRUM SPF30- zinc oxide lotion

Raw Elements Baby Kids Broad Spectrum SPF30 by

Drug Labeling and Warnings

Raw Elements Baby Kids Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by Raw Elements LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 am-2 pm
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

Helianthus Annuus (Organic Sunflower) Seed Oil, Cera Alba (Organic Beeswax), Cocos Nucifera (Organic Coconut) Oil, Theobroma Cacao (Organic Cocoa) Seed Butter, Calendula Officinalis (Organic Calendula) Flower Extract, Organic Chamomilla Recutita (Organic Chamomile) Flower Extract, Rosmarinus Officinalis (Natural Rosemary) Leaf Extract, Tocopherol (Natural Sunflower Vitamin E)

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-442-6676

Package Labeling:

INGREDIENTS AND APPEARANCE

RAW ELEMENTS BABY KIDS BROAD SPECTRUM SPF30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70680-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	250 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ROSEMARY (UNII: IJ67X351P9)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70680-307-00	85 g in 1 CAN; Type 0: Not a Combination Product	04/15/2019

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)