SPL v2
SPL
SPL Set ID ece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca
Route
TOPICAL
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Aloe Vera Leaf Ascorbyl Palmitate Butyloctyl Salicylate Coconut Oil Green Tea Leaf Cucumber Glycerin Sunflower Oil Hydrogenated Methyl Abietate Linseed Oil Nelumbo Nucifera Flower Sage Methyl Alcohol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-24

Description

Avobenzone 3.00 %                           Sunscreen                                             Octisalate 5.00 %                              Sunscreen Octocrylene 5.00 %                            Sunscreen


Medication Information

Description

Avobenzone 3.00 %                           Sunscreen                                             Octisalate 5.00 %                              Sunscreen Octocrylene 5.00 %                            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
Section 50565-1

Section 55105-1

Warnings

For external use only.

Do not use ondamaged or broken skin

When using this productkeep out of eyes.

Rinse with water to remove.

Stop use and ask doctorrash 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

Hold container 4 to 6 inches from the scalp to apply. Spray liberally onto your part or other areas where your scalp is exposed and spread evenly

with your fingertips 15 minutes before sun exposure. Do not spray directly on to face. Reapply: After 80 minutes of swimming or sweating.

Immediately after towel drying. At least every 2 hours.

Product Label

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil,

Camellia Sinensis (Green Tea) Extract, Cucumis Sativus (Cucumber) Extract, Glycerin, Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Linum Usitatissimum (Linseed) Oil, Nelumbo Nucifera (Lotus) Extract, Salvia Officinalis (Sage) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

Active Ingredient                               

Avobenzone 3.00 %                           Sunscreen                                            

Octisalate 5.00 %                              Sunscreen

Octocrylene 5.00 %                            Sunscreen


Structured Label Content

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
Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings

For external use only.

Do not use ondamaged or broken skin

When using this productkeep out of eyes.

Rinse with water to remove.

Stop use and ask doctorrash 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 (DIRECTIONS)

Hold container 4 to 6 inches from the scalp to apply. Spray liberally onto your part or other areas where your scalp is exposed and spread evenly

with your fingertips 15 minutes before sun exposure. Do not spray directly on to face. Reapply: After 80 minutes of swimming or sweating.

Immediately after towel drying. At least every 2 hours.

Product Label (Product label)

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil,

Camellia Sinensis (Green Tea) Extract, Cucumis Sativus (Cucumber) Extract, Glycerin, Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Linum Usitatissimum (Linseed) Oil, Nelumbo Nucifera (Lotus) Extract, Salvia Officinalis (Sage) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

Active Ingredient                                (Active ingredient                               )

Avobenzone 3.00 %                           Sunscreen                                            

Octisalate 5.00 %                              Sunscreen

Octocrylene 5.00 %                            Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)