MedPath

Airfit Invisible Sunscreen

Approved
Approval ID

3c3f4386-9e85-18d7-e063-6394a90a0f9a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 24, 2025

Manufacturers
FDA

Melixir Inc.

DUNS: 118641309

Products 1

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

HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code87038-100
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 24, 2025
FDA Product Classification

INGREDIENTS (48)

AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
AZADIRACHTA INDICA FLOWERInactive
Code: 3TE8A92UPM
Classification: IACT
CORALLINA OFFICINALISInactive
Code: 4004498D06
Classification: IACT
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATEInactive
Code: 255PIF62MS
Classification: IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEInactive
Code: YA22H34H9Q
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
COCCINIA GRANDIS FRUITInactive
Code: VLJ6WOT3K5
Classification: IACT
HYALURONIC ACIDInactive
Code: S270N0TRQY
Classification: IACT
MORINGA OLEIFERA SEED OILInactive
Code: REM6A5QMC0
Classification: IACT
OCIMUM BASILICUM (BASIL) OILInactive
Code: Z129UMU8LE
Classification: IACT
BEHENYL ACRYLATE POLYMERInactive
Code: D64PM5UT4U
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
AMBER POWDERInactive
Code: 70J9Z0J26P
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
CUPRESSUS SEMPERVIRENS OILInactive
Code: M7QUY89S4O
Classification: IACT
KALEInactive
Code: 0Y3L4J38H1
Classification: IACT
GRAPEFRUIT OILInactive
Code: YR377U58W9
Classification: IACT
HOMOSALATEActive
Quantity: 70 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
SODIUM STEAROYL GLUTAMATEInactive
Code: 65A9F4P024
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HOLY BASIL LEAFInactive
Code: SCJ765569P
Classification: IACT
CARROTInactive
Code: L56Z1JK48B
Classification: IACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATEInactive
Code: F01RIY4371
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
RICE GERMInactive
Code: 7N2B70SFEZ
Classification: IACT
CURCUMA LONGA (TURMERIC) ROOTInactive
Code: 856YO1Z64F
Classification: IACT
OCTOCRYLENEActive
Quantity: 50 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB
VINYLPYRROLIDONE/EICOSENE COPOLYMERInactive
Code: 035MV9S1C3
Classification: IACT
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
GLYCINE SOJA (SOYBEAN) OIL UNSAPONIFIABLESInactive
Code: WZ7DY7GBV6
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
BETA-CAROTENEInactive
Code: 01YAE03M7J
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, D-Inactive
Code: A7E6112E4N
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
MELIA AZADIRACHTA LEAFInactive
Code: HKY915780T
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
PINUS SYLVESTRIS LEAF OILInactive
Code: 5EXL5H740Y
Classification: IACT
EGGPLANTInactive
Code: W5K7RAS4VK
Classification: IACT
LIMONENE, (+)-Inactive
Code: GFD7C86Q1W
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/20/2025

Airfit Invisible™
Sunscreen
SPF 50

Broad Spectrum

1.7 fl. oz. / 50 mL

melixir

sunscreen

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/20/2025

Indication & Usage

  • helps prevent sunbumn
  • 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.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/20/2025

Purpose

  • helps prevent sunbumn
  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/20/2025

Keep out of reach of childern

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/20/2025

Active ingredients

Avobenzone 3%
Homosalate 7%
Octisalate 5%
Octocrylene 5%

WARNINGS SECTION

LOINC: 34071-1Updated: 7/20/2025

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 occurs.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/20/2025

Directions

  • For sunscreen use:

-Apply generously 15 minutes before sun exposure.

-Reapply at least every 2 hours or after 80 minutes of swimming or sweating.

  • 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 a Broad Spectrum SPF value 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.

  • Children under 6 months of age:

-Ask a doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/20/2025

Inactive ingredients

Water (Aqua), Butyloctyl Salicylate, Glycerin,
Dimethicone, Poly C10-30 Alkyl Acrylate, VP/Eicosene Copolymer, Ce-
tearyl Alcohol Niacinamide, Sodium Stearoyl Glutamate, Ammonium Poly-
acryloyldimethyl Taurate, Hydroxyacetophenone, Phenoxyethanol, Gly-
cine Soja (Soybean) Ol, Tocopheryl Acetate, Panthenol, Pentaerythrityl
Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Xanthan Gum, Propanediol, Tri-
sodium Ethylenediamine Disuccinate, Citrus Paradisi Peel Ol, Melia Aza-
dirachta Leaf Extract, Melia Azadirachta Flower Extract, Corallina Offic
inalis Extract, Cupressus Sempervirens Leaf/Nut/Stem Oil, Hydrolyzed
Hyaluronic Acid, Oryza Sativa (Rice) Extract, Ocimum Basilicum (Basil) ol,
Pinus Sylvestris Leaf Oil, Brassica Oleracea Acephala Leaf Extract, 1,2-Hex-
anediol, Amber Powder, Coccinia Indica Fruit Extract, Solanum Melongena
(Eggplant) Fruit Extract, Ocimum Sanctum Leaf Extract, Curcuma Longa
(Turmeric) Root Extract, Sodium Hyaluronate, Potassium Sorbate, Sodium
Benzoate, Moringa Oleifera Seed Oil, Citric Acid, Beta-Carotene, Daucus
Carota Sativa (Carrot) Root Extract, Tocopherol, Limonene

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Airfit Invisible Sunscreen - FDA Drug Approval Details