Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 61c56e8d-81fc-4d58-a5db-1d82bbf972ca
Route
TOPICAL
Published
Effective Date 2015-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octocrylene (6 g)
Inactive Ingredients
Water Cetostearyl Alcohol Stearyl Alcohol Glycerin Phenoxyethanol Caprylyl Glycol Cetyl Alcohol Ceteth-10 Phosphate Coco Glucoside Methylparaben Xanthan Gum Propylparaben Sodium Hydroxide Edetate Disodium Hydrogenated Methyl Abietate Sodium Ascorbyl Phosphate .alpha.-tocopherol Acetate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-10-19

Description

Avobenzone 3.0% Homosalate 10.0% Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen



Description

Avobenzone 3.0% Homosalate 10.0% Octocrylene 6.0%

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.

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
  • 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 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-sleeve shirts, pants, hats and sunglasses

    * children under 6 months of age: Ask a doctor



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 10.0%

Octocrylene 6.0%



Inactive Ingredients

Water, Cetearyl Alcohol, Stearyl Alcohol, Glycerin, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Cetyl Alcohol, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Methylparaben, Xanthan Gum, Propylparaben, Sodium Hydroxide, Disodium EDTA, Hydrogenated Methyl Abietate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Copolymer, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Principal Display Panel

CVS

pharmacy

50+

SPORT

SUN LOTION

BROAD SPECTRUM SPF 50+

UVA/UVB protection

sunscreen

Non-greasy

Won't run into eyes

Formulated for active lifestyles

Water resistant (80 minutes)

COMPARE TO BANANA BOAT

SPORT PERFORMANCE LOTION

8.0 FL OZ (237 mL)

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.





  • May stain some fabrics


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.

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
  • 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 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-sleeve shirts, pants, hats and sunglasses

    * children under 6 months of age: Ask a doctor



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 (Active ingredients)

Avobenzone 3.0%

Homosalate 10.0%

Octocrylene 6.0%



Inactive Ingredients (Inactive ingredients)

Water, Cetearyl Alcohol, Stearyl Alcohol, Glycerin, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Cetyl Alcohol, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Methylparaben, Xanthan Gum, Propylparaben, Sodium Hydroxide, Disodium EDTA, Hydrogenated Methyl Abietate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Copolymer, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Principal Display Panel

CVS

pharmacy

50+

SPORT

SUN LOTION

BROAD SPECTRUM SPF 50+

UVA/UVB protection

sunscreen

Non-greasy

Won't run into eyes

Formulated for active lifestyles

Water resistant (80 minutes)

COMPARE TO BANANA BOAT

SPORT PERFORMANCE LOTION

8.0 FL OZ (237 mL)

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.





  • May stain some fabrics


Advanced Ingredient Data


Raw Label Data

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