BLUE LIZARD BABY SPF 50 SUNSCREEN- titanium dioxide and zinc oxide lotion 
Crown Laboratories

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.

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Blue Lizard Baby SPF 50 Sunscreen

Active Ingredients

Titanium Dioxide - 8%

Zinc Oxide - 10%

Purpose

Sunscreen

Drug Facts - Uses

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 or broken 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 reach of children • Children under 6 months: 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: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

Other Information

Inactive Ingredients

Alumina, Aluminum Stearate, Beeswax, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

Questions ?

Visit www.bluelizardsunscreen.com or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Baby 3oz Tube

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 50+

PEDIATRICIAN RECOMMENDED

mineral-based

sunscreen brand

BABY

Mineral Sunscreen

Protects your skin by acting like thousands of tiny shields that reflect UV rays.

Smart Cap TECHNOLOGY

CAP CHANGES COLOR IN HARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

P11642.01

p116472

BLUE LIZARD BABY SPF 50 SUNSCREEN 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE89.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE112 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPANEDIOL (UNII: 5965N8W85T)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-2036-3089 mL in 1 TUBE; Type 0: Not a Combination Product02/17/2020
2NDC:0316-2036-40148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/29/2020
3NDC:0316-2036-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2020
4NDC:0316-2036-105 mL in 1 PACKET; Type 0: Not a Combination Product03/02/2020
5NDC:0316-2036-45148 mL in 1 TUBE; Type 0: Not a Combination Product02/17/202002/17/2020
6NDC:0316-2036-46148 mL in 1 TUBE; Type 0: Not a Combination Product02/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/29/2020
Labeler - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-2036)

Revised: 10/2021
Document Id: ce546279-c582-2d5e-e053-2995a90a1246
Set id: 9d237fb7-4f5f-521d-e053-2a95a90a9734
Version: 2
Effective Time: 20211014
 
Crown Laboratories