OTC Medication Information: Sunscreen SPF30 Plus Broad Spectrum

SUNSCREEN SPF30 PLUS BROAD SPECTRUM- zinc oxide lotion
UV Natural International Pty Ltd

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
SPF30 Label
(click image for full-size original)

SPF30 Label
SUNSCREEN SPF30 PLUS BROAD SPECTRUM
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:29565-200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 12.9 mL in 52 mL
Inactive Ingredients
Ingredient Name Strength
GRAPE SEED OIL
TRICAPRIN
SILICON DIOXIDE
ZINC STEARATE
MACADAMIA OIL
CAMELLIA OLEIFERA LEAF
VITIS VINIFERA SEED
TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29565-200-10 52 mL in 1 TUBE None
2 NDC:29565-200-50 156 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/01/2006
Labeler — UV Natural International Pty Ltd (751681078)
Registrant — UV Natural International Pty Ltd (751681078)
Establishment
Name Address ID/FEI Operations
Aloe Vera Industries Pty Ltd 758970461 manufacture

Revised: 05/2012 UV Natural International Pty Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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