SPL v2
SPL
SPL Set ID 93301066-efba-4577-ac6b-a08b74d492d9
Route
TOPICAL
Published
Effective Date 2012-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Oxybenzone (30 mg)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-05-22

Description

Active Ingredients Octinoxate 7.5%, Oxybenzone 3.0%..............


Medication Information

Warnings and Precautions

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

For external use only

Indications and Usage

Uses

■ helps prevent sunburn

Dosage and Administration

Directions

• apply liberally 15 minutes before sun exposure

• children under 6 months of age: ask a doctor

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

Description

Active Ingredients Octinoxate 7.5%, Oxybenzone 3.0%..............

Section 44425-7

Other Information

■ protect the product in this container from excessive heat and direct sun.

Section 50565-1

Keep out of reach of children. If 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 51727-6

Inactive ingredients: PETROLATUM, ORYZA SATIVA (RICE) BRAN OIL, PARAFFIN, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, HYDROGENATED POLYISOBUTENE, GLYCINE SOJA (SOYBEAN) STEROLS, LECITHIN, GLYCINE SOJA (SOYBEAN) OIL, BENZYL ALCOHOL, BHT.

Section 51945-4

Section 53413-1

Questions? 1-800-FOR-AVON

Section 55105-1

            Purpose

................ Sunscreen

Section 55106-9

Active Ingredients

Octinoxate 7.5%, Oxybenzone 3.0%..............


Structured Label Content

Indications and Usage (34067-9)

Uses

■ helps prevent sunburn

Dosage and Administration (34068-7)

Directions

• apply liberally 15 minutes before sun exposure

• children under 6 months of age: ask a doctor

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

Warnings and Precautions (34071-1)

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

For external use only

Section 44425-7 (44425-7)

Other Information

■ protect the product in this container from excessive heat and direct sun.

Section 50565-1 (50565-1)

Keep out of reach of children. If 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 51727-6 (51727-6)

Inactive ingredients: PETROLATUM, ORYZA SATIVA (RICE) BRAN OIL, PARAFFIN, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, HYDROGENATED POLYISOBUTENE, GLYCINE SOJA (SOYBEAN) STEROLS, LECITHIN, GLYCINE SOJA (SOYBEAN) OIL, BENZYL ALCOHOL, BHT.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-800-FOR-AVON

Section 55105-1 (55105-1)

            Purpose

................ Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Octinoxate 7.5%, Oxybenzone 3.0%..............


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)