SPL v3
SPL
SPL Set ID d8b32c3d-b32c-46ee-b449-ce65de35c613
Route
TOPICAL
Published
Effective Date 2014-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (16.7 mg)
Inactive Ingredients
Coconut Oil Mineral Oil Aloe Vera Flower Propylparaben Almond Oil Jojoba Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-03-18

Description

Octinoxate 2 %


Medication Information

Description

Octinoxate 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.

Section 50570-1

Do not use on damaged or broken skin.

Section 53413-1

Questions or Comments?

Biocycle Laboratories, Inc.

16363 NW 49 Avenue

Miami, FL 33014

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
  • apply liberally 15 minutes before sun exposure.
  • do not spray directly into face. Spray on hands then apply to face
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hour
  • 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 %

Inactive Ingredients

Aloe Barbadensis Extract, Cocos Nucifera (Coconut) Oil, Fragrance (Parfum), Mineral Oil (Paraffinum Liquidum), Propylparaben, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate

Principal Display Panel 236 ml  bottle Label

Suntone

Fit for the Sun

DARK TANNING

Sunscreen Spray Oil

SPF 4

Water Resistant

(80 Minutes)

4

Contains Aloe Vera

8 FL. OZ./236mL


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.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 53413-1 (53413-1)

Questions or Comments?

Biocycle Laboratories, Inc.

16363 NW 49 Avenue

Miami, FL 33014

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
  • apply liberally 15 minutes before sun exposure.
  • do not spray directly into face. Spray on hands then apply to face
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hour
  • 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 %

Inactive Ingredients

Aloe Barbadensis Extract, Cocos Nucifera (Coconut) Oil, Fragrance (Parfum), Mineral Oil (Paraffinum Liquidum), Propylparaben, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate

Principal Display Panel 236 ml  bottle Label (PRINCIPAL DISPLAY PANEL - 236 mL  Bottle Label)

Suntone

Fit for the Sun

DARK TANNING

Sunscreen Spray Oil

SPF 4

Water Resistant

(80 Minutes)

4

Contains Aloe Vera

8 FL. OZ./236mL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)