SPL v3
SPL
SPL Set ID 22a40d93-ca67-4b7d-a95c-22f52cd6d297
Route
TOPICAL
Published
Effective Date 2024-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (8 g) Octisalate (5 g) Octocrylene (2.7 g) Oxybenzone
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Cyclomethicone 5 Propanediol Silicon Dioxide Aloe Vera Leaf Laminaria Ochroleuca Tripleurospermum Inodorum Whole Phymatolithon Calcareum Dimethicone Tribehenin Peg-20 Esters Medium-chain Triglycerides Ergothioneine Peg-100 Stearate Glyceryl Monostearate Potassium Cetyl Phosphate Polysilicone-15 Sodium Pyrrolidone Carboxylate Sorbitol Glycyrrhizinate Dipotassium Cetostearyl Alcohol Aminomethylpropanol Carbomer Homopolymer, Unspecified Type Phytate Sodium Chlorphenesin Caprylyl Glycol Phenoxyethanol Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-31

Description

Avobenzone 3%                                Sunscreen Homosalate 7%                                Sunscreen Octisalate   5%                                 Sunscreen Octocrylene 2.7%                             Sunscreen Oxybenzone 3%                               Sunscreen


Medication Information

Description

Avobenzone 3%                                Sunscreen Homosalate 7%                                Sunscreen Octisalate   5%                                 Sunscreen Octocrylene 2.7%                             Sunscreen Oxybenzone 3%                               Sunscreen

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Direction ), decreases the risk of skin cancer and early aging caused by the sun.
Section 50565-1

Section 55105-1

Warning
  • For external use only.
  • Do not use ondamaged or broken skin.
  • When using this product keep out of eyes, rinse with water to remove.
  • Stop use and ask a doctorif rash occurs
  • Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply
  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.
  • Use a water resistant sunscreen (TURO SPORT Lotion + Sunscreen BROAD SPECTRUM SPF 30) if swimming or sweating.
  • 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 a board spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10am - 2pm.
  • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months of age : ask a doctor 
Product Label

Other Information

Protect this product from excessive heat and direct sun 

Inactive Ingredients

Water, C12-C15 Alkyl Benzoate, Cyclopentasiloxane, Propanediol, Silica, Aloe Barbadensis leaf juice, laminaria ochroleuca extract, Tripleurospermum maritima extract, Algae extract, Dimethicone, Tribehenin PEG-20 esters, caprylic / Capric Triglyceride, ergothioneeine, PEG-100 stearate, glyceryl stearate, potassium cetyl phosphate, Polysilicone-15, Sodium PCA, Sorbitol, Dipotassium glycyrrhizate, Cetearyl alcohol, Aminomethyl Propanol, Carbomer, Sodium phytate, Chlorphenesin, Caprylyl glycol, Phenoxyethanol, Fragrance (Parfum)

Active Ingredients                                 

Avobenzone 3%                                Sunscreen

Homosalate 7%                                Sunscreen

Octisalate   5%                                 Sunscreen

Octocrylene 2.7%                             Sunscreen

Oxybenzone 3%                               Sunscreen


Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Direction ), decreases the risk of skin cancer and early aging caused by the sun.
Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warning
  • For external use only.
  • Do not use ondamaged or broken skin.
  • When using this product keep out of eyes, rinse with water to remove.
  • Stop use and ask a doctorif rash occurs
  • Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply
  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.
  • Use a water resistant sunscreen (TURO SPORT Lotion + Sunscreen BROAD SPECTRUM SPF 30) if swimming or sweating.
  • 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 a board spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10am - 2pm.
  • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months of age : ask a doctor 
Product Label (Product label)

Other Information (Other information)

Protect this product from excessive heat and direct sun 

Inactive Ingredients (Inactive ingredients)

Water, C12-C15 Alkyl Benzoate, Cyclopentasiloxane, Propanediol, Silica, Aloe Barbadensis leaf juice, laminaria ochroleuca extract, Tripleurospermum maritima extract, Algae extract, Dimethicone, Tribehenin PEG-20 esters, caprylic / Capric Triglyceride, ergothioneeine, PEG-100 stearate, glyceryl stearate, potassium cetyl phosphate, Polysilicone-15, Sodium PCA, Sorbitol, Dipotassium glycyrrhizate, Cetearyl alcohol, Aminomethyl Propanol, Carbomer, Sodium phytate, Chlorphenesin, Caprylyl glycol, Phenoxyethanol, Fragrance (Parfum)

Active Ingredients                                  (Active ingredients                                 )

Avobenzone 3%                                Sunscreen

Homosalate 7%                                Sunscreen

Octisalate   5%                                 Sunscreen

Octocrylene 2.7%                             Sunscreen

Oxybenzone 3%                               Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)