OTC Medication Information: Roccos Old School Sunscreen SPF 30

ROCCOS OLD SCHOOL SUNSCREEN SPF 30- octinoxate, oxybenzone and titanium dioxide cream
Rocco’s Old School

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.

Active Ingredient

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

Use

  • To help prevent sunburn from UVB radiation and

    protect against long-UVA rays linked to deep premature

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 of age

  • Consult a doctor.
  • Store at controlled room temperature 15° — 30° C

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 skinaging, skin cancer and other harmful effects of the sun.

Questions?

661-877-4280

Place Holder Text

Roccos SPF Label
(click image for full-size original)
ROCCOS OLD SCHOOL SUNSCREEN SPF 30 octinoxate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24488-009
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 13.275 mL in 177 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 10.62 mL in 177 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.655 mL in 177 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Multilevel Packaging
1 NDC:24488-009-12 177 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/16/2011
Labeler — Rocco’s Old School (961956229)
Registrant — Creations Garden Natural Products Inc. (961956229)
Establishment
Name Address ID/FEI Operations
Creations Garden Natural Products Inc. 961956229 manufacture

Revised: 02/2011 Rocco’s Old School

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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