Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID fac8fdd9-fb1c-46c6-82ad-bef24ed35ddd
Route
TOPICAL
Published
Effective Date 2011-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (4 g) Octinoxate (2.5 g) Oxybenzone (2 g) Avobenzone (1.425 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-12-20

Description

Active ingredients HOMOSALATE 8%, OCTINOXATE 5%, OXYBENZONE 4%, AVOBENZONE 2.85%............... ....................................................


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

• helps prevent sunburn

• if used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun

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

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m. – 2 p.m.

    • wear long-sleeved shirts, pants, hats, and sunglasses

Description

Active ingredients HOMOSALATE 8%, OCTINOXATE 5%, OXYBENZONE 4%, AVOBENZONE 2.85%............... ....................................................

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 50567-7

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

Section 50569-3

Stop use and ask a doctor if rash occurs

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients: WATER/EAU, DIMETHICONE, BUTYLENE GLYCOL, GLYCOLIC ACID, GLYCERIN, BEHENYL ALCOHOL, HYDROGENATED POLYISOBUTENE, TRISILOXANE, ETHYLHEXYL ISONONANOATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CETEARYL ALCOHOL, ISOHEXADECANE, PHYTOL, THIODIPROPIONIC ACID, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, ECLIPTA PROSTRATA EXTRACT, PALMITOYL LYSYL AMINOVALEROYL LYSINE, PALMITOYL TETRAPEPTIDE-10, PALMITOYL TETRAPEPTIDE-7, MELICOPE HAYESII LEAF EXTRACT, SACCHAROMYCES FERMENT LYSATE FILTRATE, THIAZOLYLALANINE, MESYLOXYBENZYL ISOBUTYLBENZENESULFONAMIDE, PEG-100 STEARATE, CETEARYL GLUCOSIDE, DIMETHICONOL, POLYSORBATE 60, PEG-150 DISTEARATE, XANTHAN GUM, ISOMALT, LECITHIN, STEARETH-20, AMMONIUM HYDROXIDE, PHENOXYETHANOL, DISODIUM EDTA, PARFUM/FRAGRANCE, CARAMEL, RED 4/CI 14700.

Section 51945-4

Section 53413-1

Questions? 1-800-FOR-AVON

Section 55105-1

                                          Purpose

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



Section 55106-9
Active ingredients

HOMOSALATE 8%, OCTINOXATE 5%, OXYBENZONE 4%,

AVOBENZONE 2.85%...................................................................

Structured Label Content

Indications and Usage (34067-9)

Uses

• helps prevent sunburn

• if used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun

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

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m. – 2 p.m.

    • wear long-sleeved shirts, pants, hats, and sunglasses

Warnings and Precautions (34071-1)

Warnings

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 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

Stop use and ask a doctor if rash occurs

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients: WATER/EAU, DIMETHICONE, BUTYLENE GLYCOL, GLYCOLIC ACID, GLYCERIN, BEHENYL ALCOHOL, HYDROGENATED POLYISOBUTENE, TRISILOXANE, ETHYLHEXYL ISONONANOATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CETEARYL ALCOHOL, ISOHEXADECANE, PHYTOL, THIODIPROPIONIC ACID, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, ECLIPTA PROSTRATA EXTRACT, PALMITOYL LYSYL AMINOVALEROYL LYSINE, PALMITOYL TETRAPEPTIDE-10, PALMITOYL TETRAPEPTIDE-7, MELICOPE HAYESII LEAF EXTRACT, SACCHAROMYCES FERMENT LYSATE FILTRATE, THIAZOLYLALANINE, MESYLOXYBENZYL ISOBUTYLBENZENESULFONAMIDE, PEG-100 STEARATE, CETEARYL GLUCOSIDE, DIMETHICONOL, POLYSORBATE 60, PEG-150 DISTEARATE, XANTHAN GUM, ISOMALT, LECITHIN, STEARETH-20, AMMONIUM HYDROXIDE, PHENOXYETHANOL, DISODIUM EDTA, PARFUM/FRAGRANCE, CARAMEL, RED 4/CI 14700.

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

HOMOSALATE 8%, OCTINOXATE 5%, OXYBENZONE 4%,

AVOBENZONE 2.85%...................................................................

Advanced Ingredient Data


Raw Label Data

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