SPL v2
SPL
SPL Set ID 3c3f4386-9e85-18d7-e063-6394a90a0f9a
Route
TOPICAL
Published
Effective Date 2025-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (70 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Xanthan Gum Azadirachta Indica Flower Corallina Officinalis Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Trisodium Ethylenediamine Disuccinate 1,2-hexanediol Coccinia Grandis Fruit Hyaluronic Acid Moringa Oleifera Seed Oil Ocimum Basilicum (basil) Oil Behenyl Acrylate Polymer Cetearyl Alcohol Sodium Hyaluronate Amber Powder Sodium Benzoate Butyloctyl Salicylate Cupressus Sempervirens Oil Kale Niacinamide Grapefruit Oil Water Glycerin Sodium Stearoyl Glutamate Ammonium Polyacryloyldimethyl Taurate Panthenol Rice Germ Holy Basil Leaf Curcuma Longa (turmeric) Root Carrot Hydroxyacetophenone Potassium Sorbate Glycine Soja (soybean) Oil Unsaponifiables Citric Acid Beta-carotene Tocopherol Vinylpyrrolidone/eicosene Copolymer .alpha.-tocopherol Acetate, D- Propanediol Melia Azadirachta Leaf Dimethicone Pinus Sylvestris Leaf Oil Phenoxyethanol Eggplant Limonene, (+)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-20

Description

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

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.


Medication Information

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.

Description

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

Uses

· helps prevent sunburn

. 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.

Section 51945-4

Airfit Invisible™

Sunscreen

SPF 50

Broad Spectrum

1.7 fl. oz. / 50 mL

melixir

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.
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.

Active Ingredients



Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 5%

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.
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

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.

Structured Label Content

Uses (USES)

· helps prevent sunburn

. 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.

Section 51945-4 (51945-4)

Airfit Invisible™

Sunscreen

SPF 50

Broad Spectrum

1.7 fl. oz. / 50 mL

melixir

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.

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.
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.

Active Ingredients (Active ingredients)



Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 5%

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.
Inactive Ingredients (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

Keep Out of Reach of Childern (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.

Advanced Ingredient Data


Raw Label Data

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