Elizabeth Arden Eight Hour Cream Lip Protectant Stick Spf 15

Elizabeth Arden Eight Hour Cream Lip Protectant Stick Spf 15
SPL v1
SPL
SPL Set ID 2a0ac6aa-0315-d79e-e063-6294a90a9c53
Route
TOPICAL
Published
Effective Date 2020-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 mg) Octinoxate (7.49475 mg) Oxybenzone (3 mg) Petrolatum (30.99938 mg)
Inactive Ingredients
Bis-diglyceryl Polyacyladipate-2 Hydrogenated Polyisobutene (1300 Mw) Beeswax Ceresin Bht Acid Yellow 23 Aluminum Lake Lanolin Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Alpha-tocopherol Acetate Iron Oxides Benzoic Acid Shea Butter Coconut Oil Polyethylene Octyldodecyl Neopentanoate Mica Hexyl Laurate Polybutene (1400 Mw) Diisostearyl Malate Synthetic Wax (1200 Mw) Polyglyceryl-4 Isostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-01
Description

Active Ingredients Purpose PETROLATUM 30.2% ............. Skin Protectant PADIMATE O 8.0%....................Sunscreen OXYBENZONE 3.0%.................Sunscreen

Medication Information

Indications and Usage
  • Helps prevent sunburn
  • Temporarily protects and helps relieve
  • chapping
  • peeling or flaking due to minor sunburn
  • windburn
  • cracked lips
Dosage and Administration

As needed

Description

Active Ingredients Purpose PETROLATUM 30.2% ............. Skin Protectant PADIMATE O 8.0%....................Sunscreen OXYBENZONE 3.0%.................Sunscreen

Uses

Uses

  • helps prevent sunburn
  • Temporarily protects and helps relieve

- chapping

- peeling or flaking due to minor sunburn

- windburn

- cracked lips

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

Skin Protectant

Warnings

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 prevent sunburn, not skin cancer or early skin aging.

  • For external use only
  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs or if condition lasts more than 7 days.
  • 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

PETROLATUM 30.2% ............. Skin Protectant

PADIMATE O 8.0%....................Sunscreen

OXYBENZONE 3.0%.................Sunscreen

Directions for Use

Directions

  • Apply liberally as often as necessary

For Sunscreen Use:

  • Apply liberally 15 minutes before sun exposure
  • reapply:

- at least every 2 hours

  • children under 6 months: Ask a doctor.
Inactive Ingredients

RICINUS COMMUNIS (CASTOR) SEED OIL, OZOKERITE, GLYCERYL ROSINATE, CETYL LACTATE, LANOLIN OIL, MYRISTYL LACTATE, CETYL ACETATE, EUPHORBIA CERIFERA (CANDELILLA) WAX/CANDELILLA CERA/CIRE DE CANDELILLA, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, MYRISTYL ALCOHOL, ACETYLATED LANOLIN ALCOHOL, BEESWAX/CERA ALBA/CIRE D'ABEILLE, CAPRYLYL GLYCOL, GLYCINE SOJA (SOYBEAN) OIL, METHYLSTYRENE/VINYLTOLUENE COPOLYMER, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, PARFUM/FRAGRANCE, TOCOPHEROL, ZEA MAYS (CORN) OIL, BHT, CITRAL, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Structured Label Content

Uses

Uses

  • helps prevent sunburn
  • Temporarily protects and helps relieve

- chapping

- peeling or flaking due to minor sunburn

- windburn

- cracked lips

Indications and Usage (34067-9)
  • Helps prevent sunburn
  • Temporarily protects and helps relieve
  • chapping
  • peeling or flaking due to minor sunburn
  • windburn
  • cracked lips
Dosage and Administration (34068-7)

As needed

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

Skin Protectant

Warnings

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 prevent sunburn, not skin cancer or early skin aging.

  • For external use only
  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs or if condition lasts more than 7 days.
  • 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

PETROLATUM 30.2% ............. Skin Protectant

PADIMATE O 8.0%....................Sunscreen

OXYBENZONE 3.0%.................Sunscreen

Directions for Use

Directions

  • Apply liberally as often as necessary

For Sunscreen Use:

  • Apply liberally 15 minutes before sun exposure
  • reapply:

- at least every 2 hours

  • children under 6 months: Ask a doctor.
Inactive Ingredients

RICINUS COMMUNIS (CASTOR) SEED OIL, OZOKERITE, GLYCERYL ROSINATE, CETYL LACTATE, LANOLIN OIL, MYRISTYL LACTATE, CETYL ACETATE, EUPHORBIA CERIFERA (CANDELILLA) WAX/CANDELILLA CERA/CIRE DE CANDELILLA, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, MYRISTYL ALCOHOL, ACETYLATED LANOLIN ALCOHOL, BEESWAX/CERA ALBA/CIRE D'ABEILLE, CAPRYLYL GLYCOL, GLYCINE SOJA (SOYBEAN) OIL, METHYLSTYRENE/VINYLTOLUENE COPOLYMER, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, PARFUM/FRAGRANCE, TOCOPHEROL, ZEA MAYS (CORN) OIL, BHT, CITRAL, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:03.252639 · Updated: 2026-03-14T23:06:20.316420