Ea 8hr Lip Protectant Stick Sheer Tints

Ea 8hr Lip Protectant Stick Sheer Tints
SPL v3
SPL
SPL Set ID b671d630-2b71-66d2-e053-2a95a90a8461
Route
TOPICAL
Published
Effective Date 2019-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Padimate O (8 mg) Petrolatum (30.2 mg) Oxybenzone (3 mg)
Inactive Ingredients
Cetyl Acetate Titanium Dioxide Fd&c Yellow No. 5 Cetyl Lactate Butylated Hydroxytoluene Caprylyl Glycol Phenoxyethanol Ferric Oxide Yellow Soybean Oil High Density Polyethylene Lanolin Oil Fd&c Yellow No. 6 Myristyl Lactate Carnauba Wax Glyceryl Rosinate Tocopherol .beta.-citronellol, (r)- Limonene, (+)- Corn Oil Castor Oil White Wax D&c Red No. 6 D&c Red No. 7 Mica Ceresin Citral Linalool, (+/-)- Ferrosoferric Oxide D&c Red No. 28 Ferric Oxide Red Candelilla Wax Acetylated Lanolin Alcohols Microcrystalline Wax Geraniol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-17
Description

OCTINOXATE 7.5%...................Sunscreen OXYBENZONE 3.0%.................Sunscreen AVOBENZONE 2.0%.................Sunscreen

Medication Information

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

As needed

Description

OCTINOXATE 7.5%...................Sunscreen OXYBENZONE 3.0%.................Sunscreen AVOBENZONE 2.0%.................Sunscreen

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

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

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

Carton Art

Directions

Directions

■ Apply liberally as often as necessary



For Sunscreen Use:

■ Apply liberally 15 minutes before sun exposure

■ reapply:

■ at least every 2 hours

■ use a water resistant sunscreen if swimming or sweating

■ children under 6 months: Ask a doctor.

Active Ingredients

OCTINOXATE 7.5%...................Sunscreen

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

AVOBENZONE 2.0%.................Sunscreen

Inactive Ingredients

POLYBUTENE, BIS-DIGLYCERYL POLYACYLADIPATE-2, DIISOSTEARYL MALATE, POLYETHYLENE, OZOKERITE, LANOLIN, OCTYLDODECYL NEOPENTANOATE, HYDROGENATED POLYISOBUTENE, SYNTHETIC FLUORPHLOGOPITE, CETYL

PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, SYNTHETIC WAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, CERA ALBA (BEESWAX (CIRE D’ABEILLE)), COCOS NUCIFERA (COCONUT) OIL, TOCOPHERYL ACETATE, PARFUM (FRAGRANCE), BENZOIC ACID, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, BHT,

MAY CONTAIN: IRON OXIDES (CI 77491, CI 77499), MICA, RED 33 LAKE (CI 17200), RED 6 LAKE (CI 15850), RED 7 LAKE (CI 15850), TITANIUM DIOXIDE (CI 77891), YELLOW 5 LAKE (CI 19140).

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
    • 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

■ 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)

Directions (DIRECTIONS)

Directions

■ Apply liberally as often as necessary



For Sunscreen Use:

■ Apply liberally 15 minutes before sun exposure

■ reapply:

■ at least every 2 hours

■ use a water resistant sunscreen if swimming or sweating

■ children under 6 months: Ask a doctor.

Active Ingredients (ACTIVE INGREDIENTS)

OCTINOXATE 7.5%...................Sunscreen

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

AVOBENZONE 2.0%.................Sunscreen

Inactive Ingredients (INACTIVE INGREDIENTS)

POLYBUTENE, BIS-DIGLYCERYL POLYACYLADIPATE-2, DIISOSTEARYL MALATE, POLYETHYLENE, OZOKERITE, LANOLIN, OCTYLDODECYL NEOPENTANOATE, HYDROGENATED POLYISOBUTENE, SYNTHETIC FLUORPHLOGOPITE, CETYL

PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, SYNTHETIC WAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, CERA ALBA (BEESWAX (CIRE D’ABEILLE)), COCOS NUCIFERA (COCONUT) OIL, TOCOPHERYL ACETATE, PARFUM (FRAGRANCE), BENZOIC ACID, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, BHT,

MAY CONTAIN: IRON OXIDES (CI 77491, CI 77499), MICA, RED 33 LAKE (CI 17200), RED 6 LAKE (CI 15850), RED 7 LAKE (CI 15850), TITANIUM DIOXIDE (CI 77891), YELLOW 5 LAKE (CI 19140).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:41.562705 · Updated: 2026-03-14T23:02:23.126471