BADGER KIDS SPF 30 SUNSCREEN- zinc oxide lotion 
Autumn Harp, Inc.

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.

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Badger Kids SPF 30 Sunscreen

Active Ingredient

Non-Nano Uncoated Zinc Oxide 12%

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

Do not use on damaged or broken skin. Stop and ask a doctor if rash occurs.

When using this product

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Directions: • For full protection, apply liberally (2 mg/cm2 of skin) 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating Reapply: • 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 value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 am - 2 pm • Wear long sleeved shirts, pants, hats, and sunglasses • For children under 6 months: ask a doctor.

Ingredients

*Aloe Barbadensis (Aloe) Leaf Juice, *Helianthus Annuus (Sunflower) Oil, Carthamus Tinctorius (Safflower) Oleosomes, *Sucrose Cocoate (from Coconut), Water, *Citrus Aurantium Dulcis (Sweet Orange) Essential Oil, Microcrystalline Cellulose, Citric Acid (from Non-GMO Corn), Leuconostoc Ferment Filtrate (from Radish), *Glycerin (from Sustainable Palm), *Citrus Tangerina (Tangerine) Essential Oil, *Aloe Barbadensis (Aloe) Extract, Tocopherol (Sunflower Vitamin E), Gluconolactone (from Non-GMO Corn), *Vanilla Planifolia (Vanilla) CO2 Extract, Xanthan Gum, *Lecithin (from Soybean), Cellulose Gum. *=Certified Organic

Other Information:

Store at temperatures below 90°F.

Principal Display Panel

Image Components

image description

BADGER KIDS SPF 30 SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51514-0302
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SUNFLOWER OIL 
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES 
SUCROSE COCOATE 
ORANGE OIL 
CELLULOSE, MICROCRYSTALLINE 
CITRIC ACID MONOHYDRATE 
MANDARIN OIL 
ALOE VERA LEAF 
GLYCERIN 
TOCOPHEROL 
GLUCONOLACTONE 
VANILLA 
XANTHAN GUM 
LECITHIN, SOYBEAN 
CARBOXYMETHYLCELLULOSE SODIUM 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0302-1118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2013
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0302)

Revised: 9/2013
Document Id: b9f3a787-51a0-4ca6-aac1-f9bdb9ca6eba
Set id: b2361976-e1aa-4545-8e27-9ed986c1ffdf
Version: 1
Effective Time: 20130911
 
Autumn Harp, Inc.