Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1db8aab3-4965-48a2-a7da-a04ffbac08c1
Route
TOPICAL
Published
Effective Date 2016-05-19
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 Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-05-19

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
  • is 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 protective measures including:
  • limit time in the sun, specially from 10 a.m. to 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 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: 41250-440-56

Meijer

Oil Free

Sunscreen

Lotion

dermatologist tested

won't clog pores

30

Broad Spectrum

SPF 30

Water Resistant

(80 minutes)

8 fl. oz.. (236 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
  • is 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 protective measures including:
  • limit time in the sun, specially from 10 a.m. to 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


AVOBENZONE 2.0%, HOMOSALATE 13.0%, OCTISALATE 5.0%, OCTOCRYLENE 2.0%, OXYBENZONE 4.0%



Inactive Ingredients (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: 41250-440-56

Meijer

Oil Free

Sunscreen

Lotion

dermatologist tested

won't clog pores

30

Broad Spectrum

SPF 30

Water Resistant

(80 minutes)

8 fl. oz.. (236 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

All Sections (JSON)