SPL v6
SPL
SPL Set ID b5fa2883-998f-2128-e053-2995a90a5c84
Route
TOPICAL
Published
Effective Date 2020-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (5 g) Oxybenzone (2 g)
Inactive Ingredients
Mineral Oil Ethylhexyl Palmitate Coconut Oil Jojoba Oil Propylparaben Cocoa Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-22

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • helps prevent sunburn
Section 42229-5

Drug Facts

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 50570-1

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

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 to prevent sunburn, not skin cancer or early skin aging.

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • 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
  • hold apprximately 10 - 12 inches from skin to spray
  • spray into palm of hand, rub together, then apply to your face
  • do not spray directly into your face so that it won't get in your eyes.
  • rub into skin evenly to ensure appropriate coverage
  • this product provides minimum sunburn protection
  • fair skin types should use a higher spf
  • protect this product from excessive cold, heat, and direct sun
Active Ingredients

Octinoxate 5.0%

Oxybenzone 2.0%

Inactive Ingredients

mineral oil, ethylhexyl palmitate, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) oil, theobroma cacao (cocoa) seed butter, fragrance, and propylparaben.

Questions Or Comments?

Call toll free 1-800-368-7327

Principal Display Panel Bottle Label

250 ml NDC: 52854-928-01


Structured Label Content

Uses
  • helps prevent sunburn
Section 42229-5 (42229-5)

Drug Facts

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 50570-1 (50570-1)

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Purpose

Sunscreen

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 to prevent sunburn, not skin cancer or early skin aging.

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • 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
  • hold apprximately 10 - 12 inches from skin to spray
  • spray into palm of hand, rub together, then apply to your face
  • do not spray directly into your face so that it won't get in your eyes.
  • rub into skin evenly to ensure appropriate coverage
  • this product provides minimum sunburn protection
  • fair skin types should use a higher spf
  • protect this product from excessive cold, heat, and direct sun
Active Ingredients

Octinoxate 5.0%

Oxybenzone 2.0%

Inactive Ingredients

mineral oil, ethylhexyl palmitate, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) oil, theobroma cacao (cocoa) seed butter, fragrance, and propylparaben.

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-368-7327

Principal Display Panel Bottle Label (Principal Display Panel - Bottle Label)

250 ml NDC: 52854-928-01


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)