SPL v3
SPL
SPL Set ID 059a2cf8-924a-44bb-bdf6-0525bb69f49d
Route
TOPICAL
Published
Effective Date 2013-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (16.6 mg) Oxybenzone
Inactive Ingredients
Ascorbic Acid Castor Oil Mineral Oil Coconut Oil Aloe Vera Leaf Vitamin A Palmitate Alcohol .alpha.-tocopherol Acetate Alkyl (c12-15) Benzoate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-01-05

Description

Octinoxate 2 %, and Oxybenzone 2 %


Medication Information

Description

Octinoxate 2 %, and Oxybenzone 2 %

Uses
  • helps prevent sunburn
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 incinerate. Do not store at temperatures above 120 oF

Section 50570-1

Do not use on damaged or broken skin.

Section 53413-1

Questions or Comments?

Call toll free 1-800-950-2563 - www.aloeup.com

Section 55105-1

Purpose

Sunscreen

Section 60561-8

For external use only

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Directions
  • spray liberally and spread by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy condiions
  • use in well-ventillated area
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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

Octinoxate 2 %, and Oxybenzone 2 %

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Extract, Ascorbic Acid, C12-15 Alkyl Benzoate, Castor Oil, Cocos Nucifera (Coconut) Oil, Fragrance (Parfum), Mineral Oil, Retinyl Palmitate, SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate

Principal Display Panel 177 Ml Can Label

Aloe Up

DARK

TANNING

OIL

SPF

4

CONTINUOUS SPRAY

SUNSCREEN

MOISTURE

RICH FORMULA

WATER RESISTANT

(80 MINUTES)

VITAMIN A, C & E

6 FL OZ (177 mL)


Structured Label Content

Uses
  • helps prevent sunburn
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 incinerate. Do not store at temperatures above 120 oF

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 53413-1 (53413-1)

Questions or Comments?

Call toll free 1-800-950-2563 - www.aloeup.com

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

For external use only

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Directions
  • spray liberally and spread by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy condiions
  • use in well-ventillated area
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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)

Octinoxate 2 %, and Oxybenzone 2 %

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Extract, Ascorbic Acid, C12-15 Alkyl Benzoate, Castor Oil, Cocos Nucifera (Coconut) Oil, Fragrance (Parfum), Mineral Oil, Retinyl Palmitate, SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate

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

Aloe Up

DARK

TANNING

OIL

SPF

4

CONTINUOUS SPRAY

SUNSCREEN

MOISTURE

RICH FORMULA

WATER RESISTANT

(80 MINUTES)

VITAMIN A, C & E

6 FL OZ (177 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)