SPL v3
SPL
SPL Set ID c76746a5-e6d6-b146-e053-2995a90a1191
Route
TOPICAL
Published
Effective Date 2021-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9 g) Octocrylene (6.5 g) Octisalate (4.5 g) Avobenzone (3 g)
Inactive Ingredients
Glycerin Edetate Disodium Anhydrous Phenoxyethanol Chlorphenesin Propylene Glycol Cetyl Alcohol Sodium Polyacrylate (2500000 Mw) Water Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-01

Description

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

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.
Warnings

For external use only.

May stain some fabrics.

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
  • Children under 6 months: Ask a doctor. After applying, screw the cap back on and secure tightly.

  • 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
Do Not Use

on damaged or broken skin.

Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Cetyl Dimethicone, Phenoxyethanol, Cetyl Alcohol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Sodium Polyacrylate, Chlorphenesin, Disodium EDTA.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT®

KIDS

SPORT

ultra

SUNSCREEN LOTION ROLL-ON

UVA/UVB BROAD SPECTRUM SPF 60+

60+

HIGH ENDURANCE

VS. SWEAT & WATER

PERFECT FOR

ON-THE-GO OCCASIONS

FREE FROM

Oxybenzone

Octinoxate

Water Resistant (80 Minutes)

NET WT 2.5 FL OZ (75mL)

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


Structured Label Content

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.
Purpose

Sunscreen

Warnings

For external use only.

May stain some fabrics.

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
  • Children under 6 months: Ask a doctor. After applying, screw the cap back on and secure tightly.

  • 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
Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)
  • protect this product from excessive heat and direct sun
Active Ingredients

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene Glycol, Cetyl Dimethicone, Phenoxyethanol, Cetyl Alcohol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Sodium Polyacrylate, Chlorphenesin, Disodium EDTA.

Questions Or Comments? (Questions or Comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT®

KIDS

SPORT

ultra

SUNSCREEN LOTION ROLL-ON

UVA/UVB BROAD SPECTRUM SPF 60+

60+

HIGH ENDURANCE

VS. SWEAT & WATER

PERFECT FOR

ON-THE-GO OCCASIONS

FREE FROM

Oxybenzone

Octinoxate

Water Resistant (80 Minutes)

NET WT 2.5 FL OZ (75mL)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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