Your browser does not support JavaScript! SUPERNATURAL AIRBRUSHED CANVAS BROAD SPECTRUM SPF 15 SUNSCREEN BEIGE (ZINC OXIDE) CREAM [PHILOSOPHY]
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SUPERNATURAL AIRBRUSHED CANVAS BROAD SPECTRUM SPF 15 SUNSCREEN BEIGE (zinc oxide) cream
[philosophy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active Ingredients

Zinc Oxide (5.%)

Purpose

Sunscreen

Keep out of reach of children.

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

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

Warnings

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

Directions

  • apply liberally 15 minutes before sun exposure on clean, dry skin
  • use a water resistant sunscreen if swimming or sweating
  • 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 the sun, especially from 10 a.m.-2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

Inactive Ingredients

caprylyl glycol, silica, aluminum hydroxide, phenoxyethanol, triethoxycaprylylsilane, sodium dehydroacetate, bismuth oxychloride (ci 77163), mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499).

Other Information

  • protect this product from excessive heat and direct sun

Questions or Comments?

Call toll-free 1-800-568-3151 from 6 a.m.-5p.m. MST (Monday-Friday)

Outer Carton

Drug Facts Label

Base Label

SUPERNATURAL AIRBRUSHED CANVAS BROAD SPECTRUM SPF 15 SUNSCREEN  BEIGE
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50184-1027
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE882.7 mg  in 9.1 g
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL 
SILICON DIOXIDE 
ALUMINUM HYDROXIDE 
PHENOXYETHANOL 
TRIETHOXYCAPRYLYLSILANE 
SODIUM DEHYDROACETATE 
BISMUTH OXYCHLORIDE 
MICA 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50184-1027-21 in 1 BOX
1NDC:50184-1027-19.1 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2013
Labeler - philosophy (948102256)
Establishment
NameAddressID/FEIBusiness Operations
Mana Products Inc.078870292manufacture(50184-1027)

Revised: 2/2013
 
philosophy

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