MedPath

Blue Lizard Baby SPF 50 Sunscreen

Blue Lizard Baby SPF 50 Sunscreen

Approved
Approval ID

32d6e04a-fa30-ba48-e063-6394a90a1bbf

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 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.

Titanium Dioxide and Zinc Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0316-2036
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Titanium Dioxide and Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (32)

CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
ALUMINUM STEARATEInactive
Code: U6XF9NP8HM
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
ALOE BARBADENSIS LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)Inactive
Code: 035JKJ76MT
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
ETHYLHEXYL STEARATEInactive
Code: EG3PA2K3K5
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
HEXYL LAURATEInactive
Code: 4CG9F9W01Q
Classification: IACT
METHYL GLUCOSE DIOLEATEInactive
Code: FA9KFJ4Z6P
Classification: IACT
OCTYLDODECYL NEOPENTANOATEInactive
Code: X8725R883T
Classification: IACT
PEG-7 HYDROGENATED CASTOR OILInactive
Code: WE09129TH5
Classification: IACT
POLYGLYCERYL-4 ISOSTEARATEInactive
Code: 820DPX33S7
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)Inactive
Code: 25LXE464L2
Classification: IACT
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)Inactive
Code: AG75W62QYU
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 89.6 mg in 1 mL
Code: 15FIX9V2JP
Classification: ACTIB
ZINC OXIDEActive
Quantity: 112 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
CETYL DIMETHICONE 25Inactive
Code: U4AS1BW4ZB
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EUPHORBIA CERIFERA (CANDELILLA) WAXInactive
Code: WL0328HX19
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/5/2024

Blue Lizard Baby 3 oz Tube

Blue Lizard

AUSTRALIAN SUNSCREEN

50

BABY

with soothing calendula extract & organic aloe

MINERAL SUNSCREEN

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

TRUSTED BY PEDIATRICIANS

3 fl oz (89 ml)

Baby

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/5/2024

Uses

  • helps prevent sunburn

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/5/2024

Active ingredients

Titanium Dioxide 8%

Zinc Oxide 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/5/2024

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 12/5/2024

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 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: 12/5/2024

Directions

• shake well prior to use

• 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.

Keep out of reach of children

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 12/5/2024

Other information

  • protect the product in this container from excessive heat and direct sun
  • may stain some fabrics

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/5/2024

Inactive ingredients

1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Alumina, Aluminum Stearate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Hexyl Laurate, Hydroxyacetophenone, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Tocopherol, (Vitamin E), Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 12/5/2024

Questions?

call800.877.8869 or visit www.bluelizardsunscreen.com

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Blue Lizard Baby SPF 50 Sunscreen - FDA Drug Approval Details