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

ALLIES OF SKIN The One SPF-50 Invisible Sunscreen by

Drug Labeling and Warnings

ALLIES OF SKIN The One SPF-50 Invisible Sunscreen by is a Otc medication manufactured, distributed, or labeled by ALLIES GROUP PTE. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Package Labeling:3ml

Package Labeling: 20ml

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83852-438
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83852-438-50	1 in 1 BOX	12/11/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 83852-438-03	3 mL in 1 PACKET; Type 0: Not a Combination Product	12/11/2023
3	NDC: 83852-438-20	1 in 1 BOX	06/19/2024
3		20 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/11/2023

Labeler - ALLIES GROUP PTE. LTD. (595420087)