Sun Shades Sport 45+ Content Of Label

Sun Shades Sport 45+ Content Of Label
SPL v2
SPL
SPL Set ID 42a61346-ed7d-4537-b467-4585cc229aac
Route
TOPICAL
Published
Effective Date 2011-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (4.7106 g) Homosalate (25.553 g) Octisalate (7.851 g) Octocrylene (15.702 g)
Inactive Ingredients
Alcohol Alpha-tocopherol Acetate Ascorbyl Palmitate Bixa Orellana Seed Alkyl (c12-15) Benzoate Kukui Nut Oil Levomenol Macadamia Oil Phenyl Trimethicone Propylene Glycol Dibenzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-04-30

Description

Active ingredients Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%


Medication Information

Warnings and Precautions
Warnings

For External use only

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

Indications and Usage

Uses

  • provides high protection against sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water or sweating

Dosage and Administration

Directions

  • shake well before first use
  • apply evenly and liberally to all exposed areas before sun exposure
  • do not spray directly on face. Spray on hands to apply to face.
  • use in well-ventilated area
  • reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours.
  • children under 6 months of age: ask a doctor

Description

Active ingredients Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Section 34072-9
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
  • may stain some fabrics

Section 44425-7

Other information

  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

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 or irritation develops and lasts

Section 50567-7

When using this product

  • keep out of eyes. Rinse with water to remove.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Section 51727-6

Inactive ingredients

acrylates/octylacrylamide copolymer, aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, C12-15 alkyl benzoate, caprylic/capric triglyceride, disodium lauriminodipropionate tocopheryl phosphates, macadamia ternifolia seed oil, parfum, phenyl trimethicone, polyester-10, propylene glycol dibenzoate, SD alcohol 40-B, tocopherol

Section 51945-4
Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • provides high protection against sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water or sweating

Dosage and Administration (34068-7)

Directions

  • shake well before first use
  • apply evenly and liberally to all exposed areas before sun exposure
  • do not spray directly on face. Spray on hands to apply to face.
  • use in well-ventilated area
  • reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours.
  • children under 6 months of age: ask a doctor

Warnings and Precautions (34071-1)
Warnings

For External use only

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

Section 34072-9 (34072-9)
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
  • may stain some fabrics

Section 44425-7 (44425-7)

Other information

  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

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 or irritation develops and lasts

Section 50567-7 (50567-7)

When using this product

  • keep out of eyes. Rinse with water to remove.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Section 51727-6 (51727-6)

Inactive ingredients

acrylates/octylacrylamide copolymer, aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, C12-15 alkyl benzoate, caprylic/capric triglyceride, disodium lauriminodipropionate tocopheryl phosphates, macadamia ternifolia seed oil, parfum, phenyl trimethicone, polyester-10, propylene glycol dibenzoate, SD alcohol 40-B, tocopherol

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)