drug facts

drug facts
SPL v2
SPL
SPL Set ID 85524d39-732f-4123-adf5-83efb2bfd928
Route
topical
Published
Effective Date 2016-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (10 g) octisalate (5 g) octocrylene (6 g)
Inactive Ingredients
isobutane isohexadecane 2-ethylhexyl benzoate dibutyl adipate water ethylhexyl methoxycrylene sodium chloride polyethylene glycol 400 caprylyl glycol glycerin sodium citrate, unspecified form peg-8 dimethicone aloe vera leaf octyldodecanol vitamin a palmitate silicon dioxide .alpha.-tocopherol acetate ascorbic acid sodium propoxyhydroxypropyl thiosulfate silica phenoxyethanol methylparaben butylparaben ethylparaben isobutylparaben propylparaben

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-01-05

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%


Medication Information

Warnings

For external use only.

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

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

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 on face.
  • do not apply in windy condition
  • 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 broad spectrum SPF of 15 or higher and other sun protection measures including



  • limit time in the sun especially from 10.00 a.m. - 2.00 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor



Other Information


  • protect this product from excessive heat and direct sun

Inactive Ingredients

Isobutane, Water, Isohexadecane, Ethylhexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Dibutyl Adipate, Lauryl PEG-8 Dimethicone, Ethylhexyl Methoxycrylene, Sodium Chloride, PEG-8, Caprylyl Glycol, Glycerin, Sodium Citrate, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben.

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Principal Display Panel


NDC 30142-655-34

Kroger

FROM OUR FAMILY

TO YOURS

KIDS

sunscreen

50+

Broad Spectrum SPF 50+



  • Continuous Spray
  • Water Resistant (80 Minutes)
  • Quick and Even Coverage
  • Hypoallergenic

Tear Free

NET WT. 6 OZ. (170g)













Do Not Use

on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Questions Or Comments?

Call 1-800-632-6900

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



  • May stain some fabrics.
  • Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.


Structured Label Content

Warnings

For external use only.

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

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

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 on face.
  • do not apply in windy condition
  • 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 broad spectrum SPF of 15 or higher and other sun protection measures including



  • limit time in the sun especially from 10.00 a.m. - 2.00 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor



Other Information


  • protect this product from excessive heat and direct sun

Inactive Ingredients

Isobutane, Water, Isohexadecane, Ethylhexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Dibutyl Adipate, Lauryl PEG-8 Dimethicone, Ethylhexyl Methoxycrylene, Sodium Chloride, PEG-8, Caprylyl Glycol, Glycerin, Sodium Citrate, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben.

Principal Display Panel


NDC 30142-655-34

Kroger

FROM OUR FAMILY

TO YOURS

KIDS

sunscreen

50+

Broad Spectrum SPF 50+



  • Continuous Spray
  • Water Resistant (80 Minutes)
  • Quick and Even Coverage
  • Hypoallergenic

Tear Free

NET WT. 6 OZ. (170g)













Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Questions Or Comments? (Questions or Comments?)

Call 1-800-632-6900

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



  • May stain some fabrics.
  • Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.


Advanced Ingredient Data


Raw Label Data

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