FDA.reportPublic FDA data

Allies of Skin Sunless Tan SPF 50 Daily Self Tanner

Manufacturer
ALLIES GROUP PTE. LTD.
Effective date
2025-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:12

Label at a glance#

ProductAllies of Skin Sunless Tan SPF 50 Daily Self Tanner
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure7 sections

Indications and 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.

Dosage and administration

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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00% 

Homosalate 7.30%

Octocrylene 7.50% 

Octisalate 5.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • 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:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.
  • May stain or damage some fabrics or surfaces.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83852-543-00Allies of Skin Sunless Tan SPF 50 Daily Self Tanner1 in 1 BOXLIQUID12
83852-543-00Allies of Skin Sunless Tan SPF 50 Daily Self Tanner50 mL in 1 BOTTLELIQUID502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83852-543ALLIES OF SKIN SUNLESS TAN SPF 50 DAILY SELF TANNER (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LIQUID [ALLIES GROUP PTE. LTD.]2Current NDC, 2 package rows20250109_4d58de8e-875b-4b77-b0ef-b9d760aaced8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83852-54383852-543-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
LEVOMENOL24WE03BX2TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
C9-12 ALKANE7J5R5W72QMIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
CHAMOMILEFGL3685T2XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DAUCUS CAROTA SUBSP. SATIVUS SEED9M6AAX381UIACT
DIHYDROXYACETONEO10DDW6JOOIACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
DODECANE11A386X1QHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
SUNFLOWER OIL3W1JG795YIIACT
ISODODECANEA8289P68Y2IACT
LYCIUM BARBARUM FRUIT930626MWDLIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PROPANEDIOL5965N8W85TIACT
POMEGRANATE56687D1Z4DIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LOWBUSH BLUEBERRYG90PX41VP0IACT
GRAPE SEED OIL930MLC8XGGIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allies of Skin Sunless Tan SPF 50 Daily Self TannerAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEALLIES GROUP PTE. LTD.4d58de8e-875b-4b77-b0ef-b9d760aaced82025-01-07WarningsExact identifier
ndc (package): 83852-543-00
ndc (product): 83852-543
ndc11 (package): 83852054300
spl id: 2b1b02c0-7b7a-62ba-e063-6294a90aed72
spl set id: 4d58de8e-875b-4b77-b0ef-b9d760aaced8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.