FDA.reportPublic FDA data

Blue Lizard Active Sunscreen

Manufacturer
Crown Laboratories
Effective date
2024-11-25
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 20:48:41

Label at a glance#

ProductBlue Lizard Active Sunscreen
Active ingredientOCTOCRYLENE, ZINC OXIDE
Label structure10 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 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, esp...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 4%

Zinc Oxide 9.7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE 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

DOSAGE & ADMINISTRATION SECTION

  • Shake well prior to use
  • Apply liberally to dry skin 15 minutes before sun exposure
  • For topical use only
  • 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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

RECENT MAJOR CHANGES SECTION

Formatted Uses section

Formatted Directions section

Blue Lizard Active 8.75 oz Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLUE LIZARD

AUSTRALIAN SUNSCREEN

30+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 30+

TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

ACTIVE

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Bottle TECHNOLOGY

BOTTLE CHANGES COLOR IN HARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

8.75fl oz (259ml)

P11490.02

p1149002p1149002

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-2071-102023-02-13C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen
0316-2071-302023-02-13C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen
0316-2071-402023-02-13C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen
0316-2071-452023-02-13C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen
0316-2071-502023-02-13C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen
0316-2071-602023-02-13C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen
0316-2071-102023-01-30C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen
0316-2071-302023-01-30C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen
0316-2071-402023-01-30C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen
0316-2071-452023-01-30C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen
0316-2071-502023-01-30C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen
0316-2071-602023-01-30C16284748780-1f386c64a-194e-0266-e053-dadaa90a7c1aBlue Lizard Active Sunscreen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2071BLUE LIZARD ACTIVE SUNSCREEN (OCTOCRYLENE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]9Legacy NDC20241127_87aadb10-2c32-31e5-e053-2a95a90abd66.zip

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
0316-20710316-2071-10, 0316-2071-30, 0316-2071-40, 0316-2071-50, 0316-2071-60, 0316-2071-45

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

Source Document#

Source XML

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
483489cf-c472-c4f2-e063-6394a90adb2087aadb10-2c32-31e5-e053-2a95a90abd662026-01-12WarningsExact identifier
spl set id: 87aadb10-2c32-31e5-e053-2a95a90abd66

Reported adverse events (FAERS/openFDA)#

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