MedPath

Blue Lizard SPF 15 Lip Balm

Blue Lizard SPF 15 Lip Balm

Approved
Approval ID

1bf8fb7e-9d5b-86d4-e063-6294a90afddc

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 14, 2025

Manufacturers
FDA

Crown Laboratories

DUNS: 079035945

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

zinc oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0316-2085
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
zinc oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 14, 2025
FDA Product Classification

INGREDIENTS (22)

CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
.ALPHA.-TOCOPHEROL, D-Inactive
Code: N9PR3490H9
Classification: IACT
RICE BRANInactive
Code: R60QEP13IC
Classification: IACT
ALMOND OILInactive
Code: 66YXD4DKO9
Classification: IACT
HELIANTHUS ANNUUS SEED WAXInactive
Code: 42DG15CHXV
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
ROSEMARYInactive
Code: IJ67X351P9
Classification: IACT
HELIANTHUS ANNUUS FLOWERING TOPInactive
Code: BKJ0J3D1BP
Classification: IACT
BEHENYL BEHENATEInactive
Code: K8NU647RJ0
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
POLYHYDROXYSTEARIC ACID STEARATEInactive
Code: 8KQ7I65XZE
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
ZINC OXIDEActive
Quantity: 10 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
AVOCADO OILInactive
Code: 6VNO72PFC1
Classification: IACT
KAKADU PLUMInactive
Code: 0ZQ1D2FDLI
Classification: IACT
OLIVE OILInactive
Code: 6UYK2W1W1E
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/1/2025

Blue Lizard SPF 15 Lip Balm Carton

Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/11/2024

Uses

  • helps prevent sunburn

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/11/2024

Active ingredient

Zinc Oxide 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/11/2024

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 3/11/2024

Warnings

For external use only

Do not use

  • on damaged or broken skin

When using this product

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

  • rash occurs

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2025

Directions

• apply liberally 15 minutes before sun exposure

• children under 6 months of age: Ask a doctor

• reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 3/11/2024

Other information

  • Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/11/2024

Inactive ingredients

Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Oryza Sativa (Rice) Bran Extract, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ricinus Communis (Castor) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopherol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/11/2024

Questions?

Call800.877.8869 or visit www.bluelizardsunscreen.com

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Blue Lizard SPF 15 Lip Balm - FDA Drug Approval Details