Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b07535be-0935-46fb-83d7-21a91ecd53f0
Route
TOPICAL
Published
Effective Date 2016-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Homosalate (10 g) Octisalate (5 g) Octocrylene (4 g) Oxybenzone
Inactive Ingredients
Water Neopentyl Glycol Diheptanoate Propylene Glycol Benzyl Alcohol Trolamine Chlorphenesin Edetate Disodium Oleth-3 Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-02-17

Description

AVOBENZONE 2.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 4.0%, OXYBENZONE 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 2.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 4.0%, OXYBENZONE 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


Warning

For external use only

Directions
  • apply liberally15 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 .am. 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 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 4.0%,

OXYBENZONE 5.0%

Inactive Ingredients

Water, Neopentyl Glycol Diheptanoate, Styrene/Acrylates Copolymer, Propylene Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Polyglyceryl-3 Methylglucose Distearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Chlorphenesin, Fragrance, Disodium EDTA, Oleth-3, Tocopherol.

Principle Display Label


NDC 41250-389-19

meijer

Sport Sunscreen lotion

Non- Greasy

UVA/UVB Protection

30

Broad Spectrum

SPF 30

Water Resistant

(80 Minutes)

16 FL. OZ. (473 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

Warning

For external use only

Directions
  • apply liberally15 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 .am. 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 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 4.0%,

OXYBENZONE 5.0%

Inactive Ingredients

Water, Neopentyl Glycol Diheptanoate, Styrene/Acrylates Copolymer, Propylene Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Polyglyceryl-3 Methylglucose Distearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Chlorphenesin, Fragrance, Disodium EDTA, Oleth-3, Tocopherol.

Principle Display Label


NDC 41250-389-19

meijer

Sport Sunscreen lotion

Non- Greasy

UVA/UVB Protection

30

Broad Spectrum

SPF 30

Water Resistant

(80 Minutes)

16 FL. OZ. (473 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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