MedPath

HydroGlow Daily Sunscreen BROAD SPECTRUM SPF 50 UVA and UVB

Approved
Approval ID

3cab1598-5ef3-df73-e063-6394a90ab1e2

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Oct 1, 2025

Manufacturers
FDA

IHerb, LLC

DUNS: 071369826

Products 1

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

Sunscreen SPF 50

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82287-0002
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sunscreen SPF 50
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 1, 2025
FDA Product Classification

INGREDIENTS (43)

PSEUDOMONAS GLUCOSE FERMENTATION RHAMNOLIPIDSInactive
Code: PB22NX2CJL
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT
ETHYLHEXYL METHOXYCRYLENEInactive
Code: S3KFG6Q5X8
Classification: IACT
BETAINEInactive
Code: 3SCV180C9W
Classification: IACT
SHOREA STENOPTERA SEED BUTTERInactive
Code: 129R0X862G
Classification: IACT
VP/HEXADECENE COPOLYMERInactive
Code: KFR5QEN0N9
Classification: IACT
BISABOLOLInactive
Code: 24WE03BX2T
Classification: IACT
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
PENTYLENE GLYCOLInactive
Code: 50C1307PZG
Classification: IACT
SODIUM PCAInactive
Code: 469OTG57A2
Classification: IACT
SPIRODELA POLYRHIZAInactive
Code: BJS9J628MG
Classification: IACT
ISOLEUCINEInactive
Code: 04Y7590D77
Classification: IACT
THREONINEInactive
Code: 2ZD004190S
Classification: IACT
PHENYLALANINEInactive
Code: 47E5O17Y3R
Classification: IACT
SODIUM ACETYLATED HYALURONATEInactive
Code: WN66R7GL93
Classification: IACT
CERAMIDE NPInactive
Code: 4370DF050B
Classification: IACT
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT
VALINEInactive
Code: HG18B9YRS7
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
AVOBENZONEActive
Quantity: 3 mg in 100 mL
Code: G63QQF2NOX
Classification: ACTIB
DIBUTYL LAUROYL GLUTAMIDEInactive
Code: 3V7K3IA58X
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT
PROLINEInactive
Code: 9DLQ4CIU6V
Classification: IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERInactive
Code: W59H9296ZG
Classification: IACT
ASPARTIC ACIDInactive
Code: 30KYC7MIAI
Classification: IACT
DIBUTYL ETHYLHEXANOYL GLUTAMIDEInactive
Code: 0IAF2L30VS
Classification: IACT
ALANINEInactive
Code: OF5P57N2ZX
Classification: IACT
CARBOMERInactive
Code: 0A5MM307FC
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
CENTELLA ASIATICA LEAFInactive
Code: 6810070TYD
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
SERINEInactive
Code: 452VLY9402
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
DIPOTASSIUM GLYCYRRHIZATEInactive
Code: CA2Y0FE3FX
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
PCAInactive
Code: SZB83O1W42
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OCTISALATEActive
Quantity: 5 mg in 100 mL
Code: 4X49Y0596W
Classification: ACTIB
HOMOSALATEActive
Quantity: 7.3 mg in 100 mL
Code: V06SV4M95S
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/1/2025

SPF 50 sunscreenIdealove

HydroGlow Daily Sunscreen SPF 50 BROAD SPECTRUM SPF 50 UVA & UVB

100 mL / 3.3 fl oz

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/1/2025

Directions

• Apply generously 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water resistant sunscreen if swimming or sweating

DESCRIPTION SECTION

LOINC: 34089-3Updated: 10/1/2025

Made in the USA with global ingredients. Manufactured for: iHerb, LLC 17400 Laguna Canyon Rd., Suite 400 Irvine, CA 92618 info@idealovebeauty.com www.idealovebeauty.com LREV0525hgds ide10019

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/1/2025

Active Ingredients Purpose

Avobenzone 3.0%....................Sunscreen

Homosalate 7.3%.....................Sunscreen

Octisalate 5.0%........................Sunscreen

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/1/2025

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 sun.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 10/1/2025

Do not use on damaged or broken skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/1/2025

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 10/1/2025

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 10/1/2025

Stop use and ask a doctor if rash occurs.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 10/1/2025

Other information

• Store at 20°-25° (68°-77°F)

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

HEALTH CLAIM SECTION

LOINC: 69719-3Updated: 10/1/2025

Idealove™ HydroGlow Daily Sunscreen SPF 50 provides lasting moisture to skin while shielding it from the sun. This weightless, gel-based formula melts seamlessly into skin, delivering an instant boost of hydration—no white cast, no greasy residue, just a fresh, dewy glow. A luxurious blend of Hyaluronic Acid helps to replenish and retain moisture, keeping skin smooth to the touch.

Infused with a complex of amino acids, skin vitality is boosted for a healthy- looking complexion. Powered by a trio of broad-spectrum UV filters, this sunscreen defends against harmful UVA and UVB rays while working overtime to nourish, plump, and fortify your skin barrier.

• Broad Spectrum Facial Sunscreen

• Protects against UVA & UVB

• Unique Hydrating Gel Texture

• Ceramides for Barrier Protection

• Bisabolol for Sensitive Skin

• Amino Acids for Boosted Skin Vitality

• Fragrance-Free

• 100% Vegan

• Cruelty-Free

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/1/2025

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Dipropylene Glycol, Betaine, Shorea Stenoptera Seed Butter, VP/Hexadecene Copolymer, Ceramide NP, Sodium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydrolyzed Sodium Hyaluronate, PCA, Sodium PCA, Sodium Acetylated Hyaluronate, Bisabolol, Centella Asiatica Leaf Extract, Arginine, Serine, Alanine, Glycine, Threonine, Proline, Valine, Histidine, Isoleucine, Phenylalanine, Aspartic Acid, Spirodela Polyrhiza Extract, Hydroxyacetophenone, Dibutyl Lauroyl Glutamide, Dibutyl Ethylhexanoyl Glutamide, Glycolipids, Dipotassium Glycyrrhizate, Sodium Lactate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Carbomer, Pentylene Glycol, Tromethamine, Ethylhexylglycerin, Sodium Benzoate, Phenoxyethanol.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/1/2025

• 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 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

• Children under 6 months of age: Ask a doctor.

WARNINGS SECTION

LOINC: 34071-1Updated: 10/1/2025

Warnings For external use only

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HydroGlow Daily Sunscreen BROAD SPECTRUM SPF 50 UVA and UVB - FDA Drug Approval Details