ROCCOS OLD SCHOOL SUNSCREEN SPF 30- octinoxate cream

Roccos Old School by

Drug Labeling and Warnings

Roccos Old School by is a Otc medication manufactured, distributed, or labeled by Rocco's Old School, Creations Garden Natural Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

Place Holder Text

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	13.275 mL  in 177 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	10.62 mL  in 177 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.655 mL  in 177 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
SQUALENE (UNII: 7QWM220FJH)
YELLOW WAX (UNII: 2ZA36H0S2V)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-009-12	177 mL in 1 TUBE

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	Business Operations
Creations Garden Natural Products Inc.		961956229	manufacture