Elizabeth Arden Eight Hour Cream Nourishing Lip Balm Broad Spectrum Sunscreen Spf 20

Elizabeth Arden Eight Hour Cream Nourishing Lip Balm Broad Spectrum Sunscreen Spf 20
SPL v3
SPL
SPL Set ID b3c16e60-752d-6eba-e053-2995a90a2b20
Route
TOPICAL
Published
Effective Date 2020-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (4 mg) Avobenzone (3 mg)
Inactive Ingredients
Polybutene (1400 Mw) Castor Oil Nylon-12 Sunflower Oil Butylated Hydroxytoluene Ferric Oxide Red Vitamin A Palmitate .alpha.-tocopherol Acetate Astrocaryum Murumuru Seed Butter Hydrogenated Castor Oil Lanolin Microcrystalline Wax Shea Butter Glycereth-26 Ferric Oxide Yellow Linoleic Acid Alkyl (c12-15) Benzoate Yellow Wax Honey Linolenic Acid Tocopherol Butyloctyl Salicylate Petrolatum Dioctyldodecyl Dodecanedioate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-21
Description

Active Ingredients Purpose OCTINOXATE 4.0%...................................................Sunscreen AV0BENZONE 3.0%..................................................Sunscreen

Medication Information

Warnings and Precautions
  • 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 using and ask a doctor if rash occurs.
Indications and Usage
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun
Dosage and Administration
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
Description

Active Ingredients Purpose OCTINOXATE 4.0%...................................................Sunscreen AV0BENZONE 3.0%..................................................Sunscreen

Uses

Uses

- Helps prevent sunburn

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

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 55105-1

Sunscreen

Warnings

Warnings

- 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

- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Carton Art

Active Ingredients

Active Ingredients Purpose

OCTINOXATE 4.0%...................................................Sunscreen

AV0BENZONE 3.0%..................................................Sunscreen

Inactive Ingredients

POLYBUTENE, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, PETROLATUM, RICINUS COMMUNIS (CASTOR) SEED OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, NYLON-12, DIOCTYLDODECYL DODECANEDIOATE, C12-15 ALKYL BENZOATE, GLYCERETH-26, BUTYLOCTYL SALICYLATE, LANOLIN, ASTROCARYUM MURUMURU SEED BUTTER, BEESWAX/CERA ALBA/CIRE D'ABEILLE, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HONEY EXTRACT, HYDROGENATED CASTOR OIL, LINOLEIC ACID, LINOLENIC ACI, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT, RETINYL PALMITATE, TO DCOPHEROL, TOCOPHERYL ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492).

Directions for Sunscreen Use

Directions For Sunscreen Use:

- Apply liberally 15 minutes before sun exposure

- Reapply:

- at least every 2 hours

- 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 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-sleeve shirts, pants, hats, and sunglasses

- Children under 6 months: Ask a doctor.

Structured Label Content

Uses

Uses

- Helps prevent sunburn

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

Indications and Usage (34067-9)
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun
Dosage and Administration (34068-7)
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
Warnings and Precautions (34071-1)
  • 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 using and ask a doctor if rash occurs.
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 55105-1 (55105-1)

Sunscreen

Warnings

Warnings

- 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

- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Carton Art (CARTON ART)

Active Ingredients

Active Ingredients Purpose

OCTINOXATE 4.0%...................................................Sunscreen

AV0BENZONE 3.0%..................................................Sunscreen

Inactive Ingredients

POLYBUTENE, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, PETROLATUM, RICINUS COMMUNIS (CASTOR) SEED OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, NYLON-12, DIOCTYLDODECYL DODECANEDIOATE, C12-15 ALKYL BENZOATE, GLYCERETH-26, BUTYLOCTYL SALICYLATE, LANOLIN, ASTROCARYUM MURUMURU SEED BUTTER, BEESWAX/CERA ALBA/CIRE D'ABEILLE, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HONEY EXTRACT, HYDROGENATED CASTOR OIL, LINOLEIC ACID, LINOLENIC ACI, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT, RETINYL PALMITATE, TO DCOPHEROL, TOCOPHERYL ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492).

Directions for Sunscreen Use (Directions For Sunscreen Use)

Directions For Sunscreen Use:

- Apply liberally 15 minutes before sun exposure

- Reapply:

- at least every 2 hours

- 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 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-sleeve shirts, pants, hats, and sunglasses

- Children under 6 months: Ask a doctor.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:57.331047 · Updated: 2026-03-14T23:12:00.901105