FDA.reportPublic FDA data

Blue Lizard Kids Sunscreen

Manufacturer
Crown Laboratories
Effective date
2023-02-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:36:44

Label at a glance#

ProductBlue Lizard Kids Sunscreen
Active ingredientOCTOCRYLENE, ZINC OXIDE
Label structure8 sections

Indications and 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

Dosage and administration

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 includ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene - 4%

Zinc Oxide - 9.7%

Drug Facts - Uses

OTC - PURPOSE SECTION

  • 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

WARNINGS SECTION

  • 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

INSTRUCTIONS FOR USE SECTION

  • 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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Visit www.bluelizard.net or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Kids 3oz Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

P1146902P1146902

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-20610316-2061-10, 0316-2061-30, 0316-2061-40, 0316-2061-50, 0316-2061-60, 0316-2061-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
OCTOCRYLENE5A68WGF6WMACTIB
YELLOW WAX2ZA36H0S2VIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
CHLORPHENESINI670DAL4SZIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYL PALMITATE2865993309IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)AG75W62QYUIACT
HEXYL LAURATE4CG9F9W01QIACT
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT
PEG-7 HYDROGENATED CASTOR OILWE09129TH5IACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0bb5d729-5107-e387-e063-6394a90a1fce87aba532-a57f-3e27-e053-2a95a90ab3c32023-12-04WarningsExact identifier
spl set id: 87aba532-a57f-3e27-e053-2a95a90ab3c3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.