Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b3b65560-4fa1-4bdb-8178-5d87ee2fd653
Route
TOPICAL
Published
Effective Date 2016-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Homosalate (13 g) Octisalate (5 g) Octocrylene (4 g) Oxybenzone
Inactive Ingredients
Water Sorbitol Trolamine Aluminum Starch Octenylsuccinate Benzyl Alcohol Palmitic Acid Sorbitan Isostearate Stearic Acid Dimethicone Polyglyceryl-3 Distearate Carboxypolymethylene Tocopherol Edetate Disodium Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-06-02

Description

Avobenzone 2.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 2.0%, Oxybenzone 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 2.0%, Oxybenzone 4.0%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases 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-sleeved 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 13.0%, Octisalate 5.0%, Octocrylene 2.0%, Oxybenzone 4.0%

Inactive Ingredients

Water, Sorbitol, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Palmitic Acid, Sorbitan Isostearate, Stearic Acid, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben.

Principle Display Panel


NDC 59779-681-22

CVS HEALTH

30

BREAKOUT FREE FACE LOTION

BROAD SPECTRUM SPF 30 SUNSCREEN

UVA/UVB protection

Lightweight and oil free

Won't clog pores, hypoallergenic

No added fragrance

Water resistant

(80 minutes)

Dermatologist tested

3.0 FL OZ (88 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 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-sleeved 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

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 2.0%, Oxybenzone 4.0%

Inactive Ingredients

Water, Sorbitol, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Palmitic Acid, Sorbitan Isostearate, Stearic Acid, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben.

Principle Display Panel


NDC 59779-681-22

CVS HEALTH

30

BREAKOUT FREE FACE LOTION

BROAD SPECTRUM SPF 30 SUNSCREEN

UVA/UVB protection

Lightweight and oil free

Won't clog pores, hypoallergenic

No added fragrance

Water resistant

(80 minutes)

Dermatologist tested

3.0 FL OZ (88 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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