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FDA Approval

Hello Bello Mineral Sunscreen SPF 50

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Hello Bello
DUNS: 081135707
Effective Date
May 14, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Zinc oxide(100 mg in 1 g)
Titanium dioxide(80 mg in 1 g)

Products1

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

Hello Bello Mineral Sunscreen SPF 50

Product Details

NDC Product Code
73418-106
Application Number
M020
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
May 14, 2025
OCTYLDODECYL NEOPENTANOATEInactive
Code: X8725R883TClass: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08EClass: IACT
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMHClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
HEXYL LAURATEInactive
Code: 4CG9F9W01QClass: IACT
POLYGLYCERYL-4 ISOSTEARATEInactive
Code: 820DPX33S7Class: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0FClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8Class: IACT
Code: SOI2LOH54ZClass: ACTIBQuantity: 100 mg in 1 g
.ALPHA.-TOCOPHEROL ACETATE, D-Inactive
Code: A7E6112E4NClass: IACT
ALUMINAInactive
Code: LMI26O6933Class: IACT
ETHYLHEXYL STEARATEInactive
Code: EG3PA2K3K5Class: IACT
VP/HEXADECENE COPOLYMERInactive
Code: KFR5QEN0N9Class: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3Class: IACT
CETYL DIMETHICONE 25Inactive
Code: U4AS1BW4ZBClass: IACT
PROPANEDIOLInactive
Code: 5965N8W85TClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)Inactive
Code: 035JKJ76MTClass: IACT
DIMETHICONE 100Inactive
Code: RO266O364UClass: IACT
ALUMINUM STEARATEInactive
Code: U6XF9NP8HMClass: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQClass: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438UClass: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309Class: IACT
METHYL GLUCOSE DIOLEATEInactive
Code: FA9KFJ4Z6PClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
EUPHORBIA CERIFERA (CANDELILLA) WAXInactive
Code: WL0328HX19Class: IACT
PEG-7 HYDROGENATED CASTOR OILInactive
Code: WE09129TH5Class: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)Inactive
Code: 25LXE464L2Class: IACT
Code: 15FIX9V2JPClass: ACTIBQuantity: 80 mg in 1 g
APHANIZOMENON FLOSAQUAEInactive
Code: 49VG1X560XClass: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1GClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunscreen Label

HB Mineral Sunscreen Tube 050925


INDICATIONS & USAGE SECTION

Uses

Helps prevent sunburn
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 & ADMINISTRATION SECTION

Drug Facts


WARNINGS SECTION

Warnings


OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Titanium Dioxide 8%

Zinc Oxide 10%

OTC - PURPOSE SECTION

Purpose

Sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - QUESTIONS SECTION

Questions?

Support@HelloBello.com


INSTRUCTIONS FOR USE SECTION

Directions

Shake well before use

Apply liberally and spread evenly by hand 15 minutes before sun exposure

Reapply:

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

Sun Protection Measures

Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limiting time in the sun, especially from 10a.m. - 2p.m.
Wearing long-sleeved shirts, pants, hats and sunglasses

Children under six months: Ask a doctor


OTHER SAFETY INFORMATION

Other Information

Protect this product from excessive heat and direct sun

Avoid long-term exposure storage above 40°C (104°F)

May stain some fabrics

INACTIVE INGREDIENT SECTION

Inactive Ingredients

1,2-Hexanediol, Alumina, Aluminum Stearate, Aphanizomenon Flos-aquae Extract, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, 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, Potassium Sorbate, Propanediol, Sodium Benzoate, Tocopherol (Vitamin E), Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water.


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