Sunscreen Baby SPF30 Plus Broad Spectrum

Dosage form: lotion
Ingredients: ZINC OXIDE 12.9mL in 52mL
Labeler: UV Natural International Pty Ltd
NDC Code: 29565-300

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.

Zinc oxide 24.8%

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


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 Centre right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • re-apply after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two 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 sun, especially from 10am-2pm
  • wear long sleeve shirts, pants, hats and sunglasses
Children under 6 months ask your doctor.

protect this product from excessive heat and direct sun

Vitis vinifera (grape) seed oil, Caprilic/capric triglycerides, Slica, Zinc stearate, Macadami ternifolia seed oil, Camellia oleifera leaf extract (green tea), Vitis vinifera (grape) seed extract, Tocopherol, Iron oxides


  • No Added Fragrance
  • Natures Finest Oils
  • Preservative Free
  • Non Greasy
  • Moisturizing
  • Grapeseed
  • Green Tea



SUNSCREEN BABY  SPF30 PLUS BROAD SPECTRUM
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29565-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE12.9 mL  in 52 mL
Inactive Ingredients
Ingredient NameStrength
GRAPE SEED OIL 
TRICAPRIN 
SILICON DIOXIDE 
ZINC STEARATE 
MACADAMIA OIL 
CAMELLIA OLEIFERA LEAF 
VITIS VINIFERA SEED 
TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:29565-300-1052 mL in 1 TUBE
2NDC:29565-300-50156 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2006
Labeler - UV Natural International Pty Ltd (751681078)
Registrant - UV Natural International Pty Ltd (751681078)
Establishment
NameAddressID/FEIOperations
Aloe Vera Industries Pty Ltd758970461manufacture

Revised: 05/2012
 
UV Natural International Pty Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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