Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a6d0410f-fd98-4a50-a306-857d9bf5631c
Route
TOPICAL
Published
Effective Date 2013-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (13 g) Octisalate (5 g) Octocrylene (7 g) Oxybenzone (4 g)
Inactive Ingredients
Water Sorbitol Stearic Acid Trolamine Aluminum Starch Octenylsuccinate Benzyl Alcohol Sorbitan Isostearate Dimethicone Polyglyceryl-3 Distearate Tocopherol Edetate Disodium Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-06-28

Description

Active ingredients Avobenzone    3.0% Homosalate     13.0% Octisalate        5.0% Octocrylene     7.0% Oxybenzone     4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen



Description

Active ingredients Avobenzone    3.0% Homosalate     13.0% Octisalate        5.0% Octocrylene     7.0% Oxybenzone     4.0%

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

Section 42232-9
  • May stain some fabrics.

Section 55106-9

Active ingredients





Avobenzone    3.0%

Homosalate     13.0%

Octisalate        5.0%

Octocrylene     7.0%

Oxybenzone     4.0%





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 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

Inactive Ingredients

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



Principal Display Panel

Academy

SPORTS+OUTDOORS

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

Water Resistant

(80 Minutes)

Hypoallergenic

UVA/UVB Protection

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.




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

Section 42232-9 (42232-9)
  • May stain some fabrics.

Section 55106-9 (55106-9)

Active ingredients





Avobenzone    3.0%

Homosalate     13.0%

Octisalate        5.0%

Octocrylene     7.0%

Oxybenzone     4.0%





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 sleeve shirts, pants, hats and sunglasses
  •  children under 6 months of age: Ask a doctor.

Do Not Use On (Do not use on)

damaged or broken skin



Other Information (Other information)
  • protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

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



Principal Display Panel

Academy

SPORTS+OUTDOORS

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

Water Resistant

(80 Minutes)

Hypoallergenic

UVA/UVB Protection

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.




Advanced Ingredient Data


Raw Label Data

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