SPL v1
SPL
SPL Set ID 85f54074-5fd2-42a4-8f83-92a3ed0ca251
Route
TOPICAL
Published
Effective Date 2013-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Octisalate (50 mg) Avobenzone (20 mg) Homosalate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-02-08

Description

Active ingredients OCTINOXATE 7.50%, OCTISALATE 5.0%, AVOBENZONE 2.0%, HOMOSALATE 2.0%..............................


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 had been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Dosage and Administration

Uses

  • helps prevent sunburn
Description

Active ingredients OCTINOXATE 7.50%, OCTISALATE 5.0%, AVOBENZONE 2.0%, HOMOSALATE 2.0%..............................

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: WATER/EAU, GLYCERIN, DIMETHICONE, BUTYLENE GLYCOL, PEG-8, POTASSIUM CETYL PHOSPHATE, PHENYL TRIMETHICONE, CETEARYL ALCOHOL, ISODECYL ISONONANOATE, PHYTOL, POLYMETHYL METHACRYLATE, TINOSPORA CORDIFOLIA ROOT/STEM EXTRACT, PINUS TAEDA BARK EXTRACT, RETINOL/SACCHAROMYCES POLYPEPTIDE, PHAEODACTYLUM TRICORNUTUM EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, PLANKTON EXTRACT, HYDROLYZED MILK

PROTEIN, SODIUM HYALURONATE, ANDROGRAPHOLIDE, PANTHENOL, TOCOPHEROL, KAEMPFERIA GALANGA ROOT EXTRACT, ORYZANOL, CETEARYL GLUCOSIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ALCOHOL, CARBOMER, TROMETHAMINE, SODIUM DEHYDROACETATE, CHLORPHENESIN, PHENOXYETHANOL, DISODIUM EDTA.

Section 51945-4

Section 53413-1

Questions? 1-800-FOR-AVON

Section 55105-1

Purpose

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

Section 55106-9

Active ingredients

OCTINOXATE 7.50%, OCTISALATE 5.0%,

AVOBENZONE 2.0%, HOMOSALATE 2.0%..............................


Structured Label Content

Dosage and Administration (34068-7)

Uses

  • helps prevent sunburn
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 had 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: WATER/EAU, GLYCERIN, DIMETHICONE, BUTYLENE GLYCOL, PEG-8, POTASSIUM CETYL PHOSPHATE, PHENYL TRIMETHICONE, CETEARYL ALCOHOL, ISODECYL ISONONANOATE, PHYTOL, POLYMETHYL METHACRYLATE, TINOSPORA CORDIFOLIA ROOT/STEM EXTRACT, PINUS TAEDA BARK EXTRACT, RETINOL/SACCHAROMYCES POLYPEPTIDE, PHAEODACTYLUM TRICORNUTUM EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, PLANKTON EXTRACT, HYDROLYZED MILK

PROTEIN, SODIUM HYALURONATE, ANDROGRAPHOLIDE, PANTHENOL, TOCOPHEROL, KAEMPFERIA GALANGA ROOT EXTRACT, ORYZANOL, CETEARYL GLUCOSIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ALCOHOL, CARBOMER, TROMETHAMINE, SODIUM DEHYDROACETATE, CHLORPHENESIN, PHENOXYETHANOL, DISODIUM EDTA.

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 7.50%, OCTISALATE 5.0%,

AVOBENZONE 2.0%, HOMOSALATE 2.0%..............................


Advanced Ingredient Data


Raw Label Data

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