MedPath

ALLIES OF SKIN The One SPF-50 Invisible Sunscreen

ALLIES OF SKIN: The One SPF-50 Invisible Sunscreen Gel

Approved
Approval ID

36e1c61c-33ab-4a5d-853d-119c29632b08

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 9, 2025

Manufacturers
FDA

ALLIES GROUP PTE. LTD.

DUNS: 595420087

Products 1

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

AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83852-438
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 9, 2025
FDA Product Classification

INGREDIENTS (20)

ISODODECANEInactive
Code: A8289P68Y2
Classification: IACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERInactive
Code: O4I3UFO6ZF
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TRIDECYL SALICYLATEInactive
Code: AZQ08K38Z1
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
GREEN TEA LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
WATERMELONInactive
Code: 231473QB6R
Classification: IACT
CARROTInactive
Code: L56Z1JK48B
Classification: IACT
GLYCYRRHIZA GLABRAInactive
Code: 2788Z9758H
Classification: IACT
HELIANTHUS ANNUUS FLOWERING TOPInactive
Code: BKJ0J3D1BP
Classification: IACT
PUNICA GRANATUM ROOT BARKInactive
Code: CLV24I3T1D
Classification: IACT
TETRAHEXYLDECYL ASCORBATEInactive
Code: 9LBV3F07AZ
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
ROSEMARYInactive
Code: IJ67X351P9
Classification: IACT
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
HOMOSALATEActive
Quantity: 70 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 100 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/6/2025

Package Labeling:90ml

Outer Package 03Inner Package 03

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/7/2023

Uses:

• Helps prevent sunburn. • Higher SPF gives 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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 12/7/2023

Other Information:

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/7/2023

Active Ingredients

Avobenzone 3.00%,

Homosalate 7.00%,

Octocrylene 10.00%,

Octisalate 5.00%

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 12/7/2023

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 or irritation develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/7/2023

Directions:

• Apply liberally 15 minutes before sun exposure and as needed. • 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 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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/7/2023

Inactive Ingredients:

Isododecane, Dimethicone/bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Tridecyl Salicylate, Aloe Barbadensis Leaf Extract, Camellia Sinensis (Green Tea) Extract, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Punica Granatum (Pomegranate) Extract, Rosmarinus Officinalis (Rosemary) Extract, Rubus Idaeus (Raspberry) Oil, Niacinamide, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E)

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

ALLIES OF SKIN The One SPF-50 Invisible Sunscreen - FDA Drug Approval Details