drug facts

drug facts
SPL v1
SPL
SPL Set ID d9694e45-b59c-4269-83b5-f7c3e3ce0a94
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 (10 g) octisalate (5 g) octocrylene
Inactive Ingredients
water ethylhexyl palmitate sorbitol diethylhexyl syringylidenemalonate trolamine glyceryl monostearate peg-100 stearate medium-chain triglycerides edetate disodium oleth-3 tocopherol aloe vera leaf sodium ascorbyl phosphate benzyl alcohol chlorphenesin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-06-28

Purpose

Sunscreen

Description

Active ingredients Avobenzone    3.0% Homosalate     10.0% Octisalate        5.0% Octocrylene     10.0%


Medication Information

Warnings

For external use only

Active Ingredient

Active ingredients





Avobenzone    3.0%

Homosalate     10.0%

Octisalate        5.0%

Octocrylene     10.0%





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

Purpose

Sunscreen



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.

Other Information
  • protect the product from excessive heat and direct sun.

Inactive Ingredients

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Diethylhexyl Syringylidenemalonate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG-100 Stearate, Caprylic/

Capric Triglyceride, Disodium EDTA, Oleth-3, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.

Description

Active ingredients Avobenzone    3.0% Homosalate     10.0% Octisalate        5.0% Octocrylene     10.0%

Principal Display Panel

Academy

SPORTS+OUTDOORS

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

Water Resistant

(80 Minutes)

Hypoallergenic

UVA/UVB Protection

8 FL. OZ.

(236 mL)







Section 42232-9
  • May stain some fabrics.

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.



Section 50566-9

Stop use and ask a doctor if rash occurs



Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.



Section 50570-1

Do not use on damaged or broken skin




Structured Label Content

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredients





Avobenzone    3.0%

Homosalate     10.0%

Octisalate        5.0%

Octocrylene     10.0%





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

Purpose

Sunscreen



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.

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

Inactive Ingredients (Inactive ingredients)

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Diethylhexyl Syringylidenemalonate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG-100 Stearate, Caprylic/

Capric Triglyceride, Disodium EDTA, Oleth-3, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.

Principal Display Panel

Academy

SPORTS+OUTDOORS

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

Water Resistant

(80 Minutes)

Hypoallergenic

UVA/UVB Protection

8 FL. OZ.

(236 mL)







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

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.



Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs



Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.



Section 50570-1 (50570-1)

Do not use on damaged or broken skin




Advanced Ingredient Data


Raw Label Data

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