BLUE LIZARD KIDS SUNSCREEN- octocrylene 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 Kids Sunscreen

Active Ingredients

Octocrylene - 4%

Zinc Oxide - 9.7%

Drug Facts - 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 risk of skin cancer and early skin aging caused by the sun

Warnings

When using this product
Keep out of eyes. Rinse with water to remove
Stop use and ask a 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

Protect the product in this container from excessive heat and direct sun
May stain some fabrics

Inactive Ingredients

Beeswax, 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, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

Questions?

Visit www.bluelizard.net or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Kids 3oz Label

BLUE LIZARD

AUSTRALIAN SUNSCREEN

30+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 30+

No. 1 PEDIATRICIAN RECOMMENDED
mineral-based sunscreen brand

KIDS

mineral-based sunscreen

combining mineral and chemical UV protectors for water-resistant performance you can trust.

Smart Cap TECHNOLOGY

CAP TURNS BLUE INHARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

P11469.02

P1146902

BLUE LIZARD KIDS SUNSCREEN
octocrylene and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0316-2061
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	41.8 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	104.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CHLORPHENESIN (UNII: I670DAL4SZ)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0316-2061-10	5 mL in 1 PACKET; Type 0: Not a Combination Product	01/02/2019	01/31/2022
2	NDC:0316-2061-30	89 mL in 1 TUBE; Type 0: Not a Combination Product	01/02/2019	01/31/2023
3	NDC:0316-2061-40	1 in 1 CARTON	01/02/2019	01/31/2023
3		148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:0316-2061-50	259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/02/2019	05/31/2023
5	NDC:0316-2061-60	3785 mL in 1 JUG; Type 0: Not a Combination Product	01/02/2019	04/30/2021
6	NDC:0316-2061-45	148 mL in 1 TUBE; Type 0: Not a Combination Product	01/02/2019	11/30/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/02/2019	05/31/2023

Labeler - Crown Laboratories (079035945)

Name	Address	ID/FEI	Business Operations
Establishment
Crown Laboratories		079035945	manufacture(0316-2061)

Revised: 2/2023

Document Id: f49d2b8b-7bcf-80da-e053-2995a90a3d12

Set id: 87aba532-a57f-3e27-e053-2a95a90ab3c3

Version: 6

Effective Time: 20230213

Crown Laboratories