71011-004 Sunscreen

71011-004 Sunscreen
SPL v1
SPL
SPL Set ID 713f3bf5-ee59-516a-e053-2995a90a811c
Route
TOPICAL
Published
Effective Date 2018-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxybenzone (4 g) Octisalate (2 g) Octinoxate (7.5 g)
Inactive Ingredients
Glycerin Lanolin Dmdm Hydantoin Water Stearic Acid Hexadecanal Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-07-18

Description

Octinoxate 7.5%,Octisalate 2.0%,Oxybenzone 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5%,Octisalate 2.0%,Oxybenzone 4.0%

Uses

Helps prevent sunburn

Section 51945-4

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging. This products has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs

Directions

Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

Active Ingredients

Octinoxate 7.5%,Octisalate 2.0%,Oxybenzone 4.0%

Inactive Ingredients

Water, Stearic acid , Hexadecan-1-ol, Lanolin , Mineral oil, Glyceryl Stearate, POLYSORBATE80, Sorbitan Stearate,Glycerin,DMDM Hydantoin,Frangrance

Keep Out of Reach of Children.

If product swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Helps prevent sunburn

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings: (WARNINGS:)

Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging. This products has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs

Directions

Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

Active Ingredients

Octinoxate 7.5%,Octisalate 2.0%,Oxybenzone 4.0%

Inactive Ingredients (Inactive ingredients)

Water, Stearic acid , Hexadecan-1-ol, Lanolin , Mineral oil, Glyceryl Stearate, POLYSORBATE80, Sorbitan Stearate,Glycerin,DMDM Hydantoin,Frangrance

Keep Out of Reach of Children. (Keep out of reach of children.)

If product swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)