Your browser does not support JavaScript! BLUE LIZARD BABY (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]
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BLUE LIZARD BABY (titanium dioxide and zinc oxide) lotion
[Crown Laboratories]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph 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

Titanium Dioxide - 5%

Zinc Oxide - 10%

Questions

Questions: Visit www.bluelizard.net or Call Toll Free 800.877.8869

Drug Facts - Uses

Uses

  • Helps prevent sunburn and photodamage caused by UVA/UVB exposure
  • Higher SPF gives more sunburn protection
  • If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun

Drug Facts - Warnings, Directions, and Other Information

Warnings

  • When using this product
  • Keep out of eyes
  • Rinse with water to remove
  • Stop use and ask doctor if
  • Rash or irritation occurs
  • Do not use
  • On damaged skin
  • if allergic to any ingredient
  • If swallowed, get medical help or contact a Poison Control Center
Directions
  • Shake well prior to use
  • Apply liberally to dry skin 15 minutes before sun exposure
  • For topical use only
  • Keep out of the reach of children
  • Children under 6 months of age: Ask a doctor
  • 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 value of 15 or higher and other sun protection measures including: Limit time in the sun especially from 10 a.m.- 2 p.m.
  • Wear long sleeved shirts, pants, hats, and sunglasses
  • Reapply to dry skin:
  • At least every two hours
  • Use a water resistant sunscreen if swimming or sweating

Other Information:

  • Protect the product from excessive heat and direct sun
  • May stain some fabrics

Inactive Ingredients

Inactive Ingredients:

Beeswax, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl Dimethicone Copolyol, Chlorphenesin, Disodium EDTA, Ethylhexyl Palmititate, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Octododecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyeryl-4 Isostearate, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Trimethylated Silica/Dimethicone, VP Hexadecene Copolymer

Blue Lizard Baby 5oz Label

Blue Lizard Australian Sunscreen - Baby

Broad Spectrum SPF 30+

Zinc Oxide and Titanium Dioxide Formula

Paraben Free Chemical Free Fragrance Free

BLBABY5oz.jpgBlue Lizard Baby 5oz Label

BLUE LIZARD BABY 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0316-2035
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE54 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE108 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) 
ALKYL (C12-15) BENZOATE 
EDETATE DISODIUM 
ETHYLHEXYL PALMITATE 
ETHYLHEXYL STEARATE 
CAPRYLYL GLYCOL 
HEXYL LAURATE 
HYDROGENATED CASTOR OIL 
METHYL GLUCOSE DIOLEATE 
CHLORPHENESIN 
OCTYLDODECYL NEOPENTANOATE 
PEG-7 HYDROGENATED CASTOR OIL 
POLYGLYCERYL-4 ISOSTEARATE 
PHENOXYETHANOL 
PROPANEDIOL 
WATER 
SORBITAN MONOOLEATE 
STEARIC ACID 
.ALPHA.-TOCOPHEROL ACETATE 
DIMETHICONE 
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) 
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-2035-2037 mL in 1 BOTTLE, PLASTIC
2NDC:0316-2035-3089 mL in 1 TUBE
3NDC:0316-2035-40148 mL in 1 BOTTLE, PLASTIC
4NDC:0316-2035-50259 mL in 1 BOTTLE, PLASTIC
5NDC:0316-2035-603785 mL in 1 JUG
6NDC:0316-2035-105 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/08/2003
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-2035)

Revised: 1/2013
 
Crown Laboratories

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