SPL v3
SPL
SPL Set ID 4538a09a-e0bb-4b85-95ea-8be3a881c932
Route
TOPICAL
Published
Effective Date 2014-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (25.4 mg) Homosalate (84.8 mg) Octisalate (42.4 mg) Octocrylene (23.3 mg) Oxybenzone (33.9 mg)
Inactive Ingredients
Diethylhexyl 2,6-naphthalate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Alcohol Dibutyl Maleate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-12-17

Description

Avobenzone 3%, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 4 %


Medication Information

Description

Avobenzone 3%, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 4 %

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 42229-5

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.

  • keep away from face to avoid breathing it.
  • contents under pressure - do not puncture or incinirate. Do not store at temperatures above 120 0F
Section 50570-1

Do not use on broken or damaged skin

Section 53413-1

Questions or Comments?

Call toll free 1-866-983-8582

Section 55105-1

Purpose

Sunscreen

Section 60561-8

For external use only

Warnings

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly on face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in well-ventilated areas
  • 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 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: Ask a doctor

Other Information
  • protect this product from excesive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration
Active Ingredients

Avobenzone 3%, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 4 %

Inactive Ingredients

Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Principal Display Panel 177 Ml Can Label

SUNCARE

BROAD SPECTRUM

SPF 50

WATER RESISTANT

(80 MINUTES)

OIL-FREE

CONTINUOUS SPRAY

SUNSCREEN

ULTA

6 fl oz./177 ml


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 42229-5 (42229-5)

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.

  • keep away from face to avoid breathing it.
  • contents under pressure - do not puncture or incinirate. Do not store at temperatures above 120 0F
Section 50570-1 (50570-1)

Do not use on broken or damaged skin

Section 53413-1 (53413-1)

Questions or Comments?

Call toll free 1-866-983-8582

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

For external use only

Warnings

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly on face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in well-ventilated areas
  • 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 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: Ask a doctor

Other Information (Other information)
  • protect this product from excesive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration
Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 4 %

Inactive Ingredients

Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Principal Display Panel 177 Ml Can Label (PRINCIPAL DISPLAY PANEL - 177 mL Can Label)

SUNCARE

BROAD SPECTRUM

SPF 50

WATER RESISTANT

(80 MINUTES)

OIL-FREE

CONTINUOUS SPRAY

SUNSCREEN

ULTA

6 fl oz./177 ml


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)