ALLIES OF SKIN THE ONE SPF-50 INVISIBLE SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate gel 
ALLIES GROUP PTE. LTD.

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

Drug Facts

Active Ingredients

Avobenzone 3.00%,

Homosalate 7.00%,

Octocrylene 10.00%,

Octisalate 5.00%

Purpose

Sunscreen

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.

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.

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.

Other Information:

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

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)

Package Labeling:50ml

Outer Package
Inner Package

Package Labeling:3ml

Label

Package Labeling: 20ml

Outer Package02Inner Package02

ALLIES OF SKIN THE ONE SPF-50 INVISIBLE SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83852-438
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE70 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WATERMELON (UNII: 231473QB6R)  
CARROT (UNII: L56Z1JK48B)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
ROSEMARY (UNII: IJ67X351P9)  
NIACINAMIDE (UNII: 25X51I8RD4)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83852-438-501 in 1 BOX12/11/2023
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:83852-438-033 mL in 1 PACKET; Type 0: Not a Combination Product12/11/2023
3NDC:83852-438-201 in 1 BOX06/19/2024
320 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/11/2023
Labeler - ALLIES GROUP PTE. LTD. (595420087)

Revised: 6/2024
Document Id: 1bb2d049-4f5f-3b6c-e063-6394a90a7174
Set id: 36e1c61c-33ab-4a5d-853d-119c29632b08
Version: 2
Effective Time: 20240625
 
ALLIES GROUP PTE. LTD.