ALLIES OF SKIN SUNLESS TAN SPF 50 DAILY SELF TANNER- avobenzone, homosalate, octocrylene, octisalate liquid

Allies of Skin Sunless Tan SPF 50 Daily Self Tanner by

Drug Labeling and Warnings

Allies of Skin Sunless Tan SPF 50 Daily Self Tanner 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 7.30%

Octocrylene 7.50% 

Octisalate 5.00%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn.
• Higher SPF gives more 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 the 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 the product in this container from excessive heat and direct sun.
• May stain or damage some fabrics or surfaces.

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, C9-12 Alkane, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Daucus Carota Sativa (Carrot) Seed Extract, Dihydroxyacetone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Dodecane, Ethyl Vanillin, Ethylhexylglycerin, Glycerin, Glyceryl Stearate Citrate, Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Isododecane, Lactobacillus Ferment, Lycium Barbarum Fruit Extract, Magnesium Aluminum Silicate, Octyldodecyl Neopentanoate, Phenoxyethanol, Polysorbate 20, Potassium Cetyl Phosphate, Propanediol, Punica Granatum Fruit Extract, Sodium Hyaluronate, Sodium Metabisulfite, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum

Package Labeling:

INGREDIENTS AND APPEARANCE

ALLIES OF SKIN SUNLESS TAN SPF 50 DAILY SELF TANNER 
avobenzone, homosalate, octocrylene, octisalate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83852-543
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	73 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
C9-12 ALKANE (UNII: 7J5R5W72QM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
CHAMOMILE (UNII: FGL3685T2X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
DIHYDROXYACETONE (UNII: O10DDW6JOO)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
DODECANE (UNII: 11A386X1QH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISODODECANE (UNII: A8289P68Y2)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PROPANEDIOL (UNII: 5965N8W85T)
POMEGRANATE (UNII: 56687D1Z4D)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83852-543-00	1 in 1 BOX	10/14/2024
1		50 mL in 1 BOTTLE; 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	10/14/2024

Labeler - ALLIES GROUP PTE. LTD. (595420087)