Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 5b718c50-83fe-45f2-a23e-927a5196bebe
Route
TOPICAL
Published
Effective Date 2015-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Homosalate (7 g) Octocrylene (5 g)
Inactive Ingredients
.alpha.-tocopherol Acetate Mineral Oil Panthenol Water Aloe Vera Leaf Alcohol Isobutane Isododecane Diisopropyl Adipate Caprylyl Glycol Hydrogenated Methyl Abietate Ascorbyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-10-20

Description

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen



Description

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%

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

Flammable

Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 1200 F. Do not use in the presence of a flame or spark. Keep away from sources of ignition-No smoking.

Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.



Directions
  • hold container 4-6 inches from the skin to apply
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Do not spray directly on face. Spray on hands then apply to face.
  • do not apply in windy conditions
  • use in well-ventilated area
  • 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.-2p.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 2.0%, Homosalate 7.0%, Octocrylene 5.0%



Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Copolymer, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Ascorbyl Palmitate, Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract.



Principal Display Panel

CVS

pharmacy

30

SPORT

CLEAR SPRAY

BROAD SPECTRUM SPF 30

UVA/UVB protection

sunscreen

Continuous spray

Non-greasy

Formulated for active lifestyles

Water resistant (80 minutes)

COMPARE TO BANANA BOAT

SPORT PERFORMANCE SPRAY

NET WT 6 OZ. (170 g)

When Using This Product
  • Keep away from face to avoid breathing it
  • 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 a 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

Flammable

Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 1200 F. Do not use in the presence of a flame or spark. Keep away from sources of ignition-No smoking.

Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.



Directions
  • hold container 4-6 inches from the skin to apply
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Do not spray directly on face. Spray on hands then apply to face.
  • do not apply in windy conditions
  • use in well-ventilated area
  • 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.-2p.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 2.0%, Homosalate 7.0%, Octocrylene 5.0%



Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Copolymer, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Ascorbyl Palmitate, Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract.



Principal Display Panel

CVS

pharmacy

30

SPORT

CLEAR SPRAY

BROAD SPECTRUM SPF 30

UVA/UVB protection

sunscreen

Continuous spray

Non-greasy

Formulated for active lifestyles

Water resistant (80 minutes)

COMPARE TO BANANA BOAT

SPORT PERFORMANCE SPRAY

NET WT 6 OZ. (170 g)

When Using This Product (When using this product)
  • Keep away from face to avoid breathing it
  • 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 a 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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