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Roccos Old School Sunscreen SPF 30

Dosage form: cream
Ingredients: OCTINOXATE 13.275mL in 177mL, OXYBENZONE 10.62mL in 177mL, TITANIUM DIOXIDE 2.655mL in 177mL
Labeler: Rocco's Old School
NDC Code: 24488-009

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 Ingredient

Octinoxate 7.5% ..............................................Sunscreen agent
Benzophenone-3 6%......................................Sunscreen agent
Titanium Dioxide 1.5%....................................Sunscreen agent

Use
  • To help prevent sunburn from UVB radiation and
    protect against long-UVA rays linked to deep premature
    skin-aging.

Warnings

For external use only.

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

Stop use and ask doctor if

rash or irritation develops and lasts.

Keep out of reach of children.

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

Directions
  • Apply liberally on face, neck and other
    exposed areas every morning after cleansing or at least 15
    minutes before sun exposure, or as needed.
  • Reapply if excess perspiration or product wear occurs, and after
    swimming or towel drying.
    For children under six months

For children under six months of age
  • Consult a doctor.
  • Store at controlled room temperature 15° - 30° C
    (59° - 86°F).

Inactive ingredients

Purified Water/Aqua/Eu, Allantoin,
Glyceryl Stearate and PEG-100 Stearate, Stearic Acid,
Squalene, Beeswax, Aloe Barbadensis Leaf Juice, Sodium
Hyaluronate, Carbomer, Potassium sorbate,
Sodium Benzoate

Sun Alert

Limiting sun exposure, wearing protective
clothing and using sunscreens may reduce the risks of skin
aging, skin cancer and other harmful effects of the sun.

Questions?

661-877-4280

Place Holder Text

ROCCOS OLD SCHOOL  SUNSCREEN SPF 30
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE13.275 mL  in 177 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE10.62 mL  in 177 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.655 mL  in 177 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALLANTOIN 
GLYCERYL MONOSTEARATE 
POLYOXYL 100 STEARATE 
STEARIC ACID 
SQUALENE 
YELLOW WAX 
ALOE VERA LEAF 
HYALURONATE SODIUM 
CARBOMER HOMOPOLYMER TYPE C 
POTASSIUM SORBATE 
SODIUM BENZOATE 
Packaging
#Item CodePackage Description
1NDC:24488-009-12177 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/16/2011
Labeler - Rocco's Old School (961956229)
Registrant - Creations Garden Natural Products Inc. (961956229)
Establishment
NameAddressID/FEIOperations
Creations Garden Natural Products Inc.961956229manufacture

Revised: 02/2011
Document Id: 260b397c-fd1e-4038-8e4a-a706ea78183e
Set id: 9f00e6b8-134a-40d6-979c-a350c3ee93f7
Version: 1
Effective Time: 20110216
 
Rocco's Old School

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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