Sun Shades Sport Spray 50

Sun Shades Sport Spray 50
SPL v2
SPL
SPL Set ID 1f982f03-9542-29f9-e063-6294a90a959c
Route
TOPICAL
Published
Effective Date 2021-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (13.04 g) Octisalate (8.15 g) Avobenzone (4.89 g) Homosalate (24.45 g)
Inactive Ingredients
Neopentyl Glycol Diheptanoate Diisopropyl Adipate Aloe Vera Leaf Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (40000 Mw) Simmondsia Chinensis Leaf Parfumidine Alcohol Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-01

Description

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Dosage and Administration

Directions

  • shake well before using
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from skin to apply
  • do not spray directly into face. Spray on hands, then apply to face.
  • do not apply in windy conditions
  • use a well-ventilated area
  • 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 value 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
Description

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%

Uses

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 50565-1

Keep out of reach of children. If 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.
  • keep away from face to avoid breathing it
  • do not puncture or incinerate. Contents under pressure.
Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

acrylates/octylacrylamide copolymer, alcohol denat, aloe barbadensis leaf juice, butylene glycol, diisopropyl adipate, fragrance (parfum), neopentyl glycol diheptanoate, simmondsia chinensis (jojoba) extract

Section 51945-4

Section 60561-8

Other information

  • may stain some fabrics
  • protect this product from excessive heat and direct sun
  • do not store at temperatures below 32 F (0 C) or above 120 F (49 C)
Warnings

For external use only

Flammable: do not use near heat, flame, or while smoking

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%


Structured Label Content

Uses

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
Dosage and Administration (34068-7)

Directions

  • shake well before using
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from skin to apply
  • do not spray directly into face. Spray on hands, then apply to face.
  • do not apply in windy conditions
  • use a well-ventilated area
  • 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 value 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
Section 50565-1 (50565-1)

Keep out of reach of children. If 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.
  • keep away from face to avoid breathing it
  • do not puncture or incinerate. Contents under pressure.
Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

acrylates/octylacrylamide copolymer, alcohol denat, aloe barbadensis leaf juice, butylene glycol, diisopropyl adipate, fragrance (parfum), neopentyl glycol diheptanoate, simmondsia chinensis (jojoba) extract

Section 51945-4 (51945-4)

Section 60561-8 (60561-8)

Other information

  • may stain some fabrics
  • protect this product from excessive heat and direct sun
  • do not store at temperatures below 32 F (0 C) or above 120 F (49 C)
Purpose

Sunscreen

Warnings

For external use only

Flammable: do not use near heat, flame, or while smoking

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%


Advanced Ingredient Data


Raw Label Data

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