FDA.reportPublic FDA data

Blue Lizard Face

Manufacturer
Crown Laboratories
Effective date
2023-12-05
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 21:19:10

Label at a glance#

ProductBlue Lizard Face
Active ingredientOCTINOXATE, 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

Octinoxate 5.5%

Zinc Oxide 8.0%

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:
  • At least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating

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, BHT, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caffeine, Camellia sinesis Leaf (Green Tea) Extract, Caprylyl Glycol, Chlorphenesin, Cyclomethicone, Dimethoxydiphenylsilane, Isotearyl Alcohol, Laureth-7, Lauryl PEG/PPG 18/18 Methicone, Phenoxyethanol, Polyacrylamide, Purified Water, Sodium Hyaluronate, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane

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 Face 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

FACE

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Cap TECHNOLOGY

CAP CHANGES COLOR IN HARMFUL UV LIGHT

LIGHTWEIGHT DAILY

SUN PROTECTION

P6138.12

BL Face P6138_12BL Face P6138_12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD513
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z3
OCTINOXATEACTIVE MOIETY4Y5P7MUD513
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z3
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ3
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L03
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE703
CAFFEINEINACTIVE INGREDIENT3G6A5W338E3
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ3
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z3
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B03
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQY3
LAURETH-7INACTIVE INGREDIENTZ95S6G82013
LAURYL PEG/PPG-18/18 METHICONEINACTIVE INGREDIENTZJ5S27D9NX3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
WATERINACTIVE INGREDIENT059QF0KO0R3
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V3

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-20550316-2055-10, 0316-2055-30, 0316-2055-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHOXYDIPHENYLSILANE02QB6788GCIACT
ISOSTEARYL ALCOHOLQ613OCQ44YIACT
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CYCLOMETHICONENMQ347994ZIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
YELLOW WAX2ZA36H0S2VIACT
CAFFEINE3G6A5W338EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
HYALURONATE SODIUMYSE9PPT4THIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZSOLUTION / TOPICAL11.57 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZCREAM / TOPICAL13 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZCREAM, AUGMENTED / TOPICAL7.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
CAFFEINECAFFEINE3G6A5W338ESPRAY, METERED / NASAL10 mg/1mlExact identifier — unii candidate
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
CAFFEINECAFFEINE3G6A5W338EGRANULE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZLOTION / TOPICAL3510 mgExact identifier — unii candidate
5 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZAEROSOL, FOAM / TOPICAL5.26 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
CAFFEINECAFFEINE3G6A5W338ESOLUTION / OPHTHALMIC2 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates

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
0bc824f9-7b49-09c1-e063-6294a90ae0f2ab6ab076-eea1-4091-975e-0a0caeb002132023-12-05WarningsExact identifier
spl id: 0bc824f9-7b49-09c1-e063-6294a90ae0f2
spl set id: ab6ab076-eea1-4091-975e-0a0caeb00213

Reported adverse events (FAERS/openFDA)#

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