197107 - DailyMed Details

197107

SPL v1

SPL

SPL Set ID a6271ee2-39c2-445a-bb24-f87745ac69be

Route

TOPICAL

Published

Effective Date 2013-05-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (0.568 g) Avobenzone (0.426 g)

Inactive Ingredients

Polybutene (1400 Mw) Microcrystalline Wax Petrolatum Nylon-12 Dioctyldodecyl Dodecanedioate Glycereth-26 Butyloctyl Salicylate Lanolin Astrocaryum Murumuru Seed Butter Hydrogenated Castor Oil Linoleic Acid Linolenic Acid Tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2012-07-24

Description

This daily moisturizing treatment replenishes lips with eight essential vitamins, nutrients and minerals while providing advanced broad spectrum SPF 20 sun protection against damaging UVA/UVB rays.

Indications and Usage

To use: Squeeze tube and apply liberally with self-applicator tip.

Purpose

Provides SPF 20 sun protection.

Medication Information

Indications and Usage

To use: Squeeze tube and apply liberally with self-applicator tip.

Purpose

Provides SPF 20 sun protection.

Description

This daily moisturizing treatment replenishes lips with eight essential vitamins, nutrients and

minerals while providing advanced broad spectrum SPF 20 sun protection against damaging

UVA/UVB rays.

Section 51945-4

Warnings

WARNING

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.

Otc Purpose

Provides SPF 20 sun protection.

Otc When Using

KEEP OUT OF EYES.

Inactive Ingredient

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

ACID, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT,

RETINYL PALMITATE, TOCOPHEROL, TOCOPHERYL

ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492).

Dosage & Administration

apply liberally

Otc Active Ingredient

ACTIVE INGREDIENTS: OCTINOXATE, 4.0 % W/W

AVOBENZONE, 3.0 % W/W

Otc Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN.

Structured Label Content

Section 51945-4 (51945-4)

Warnings (WARNINGS)

WARNING

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.

Description (DESCRIPTION)

This daily moisturizing treatment replenishes lips with eight essential vitamins, nutrients and

minerals while providing advanced broad spectrum SPF 20 sun protection against damaging

UVA/UVB rays.

Otc Purpose (OTC - PURPOSE)

Provides SPF 20 sun protection.

Otc When Using (OTC - WHEN USING)

KEEP OUT OF EYES.

Inactive Ingredient (INACTIVE INGREDIENT)

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

ACID, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT,

RETINYL PALMITATE, TOCOPHEROL, TOCOPHERYL

ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492).

Indications and Usage (INDICATIONS AND USAGE)

To use: Squeeze tube and apply liberally with self-applicator tip.

Dosage & Administration (DOSAGE & ADMINISTRATION)

apply liberally

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

ACTIVE INGREDIENTS: OCTINOXATE, 4.0 % W/W

AVOBENZONE, 3.0 % W/W

Otc Keep Out of Reach of Children (OTC - KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"WARNINGS": "WARNING : 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. ", "DESCRIPTION": "This daily moisturizing treatment replenishes lips with eight essential vitamins, nutrients and minerals while providing advanced broad spectrum SPF 20 sun protection against damaging UVA/UVB rays.", "OTC - PURPOSE": "Provides SPF 20 sun protection.", "OTC - WHEN USING": "KEEP OUT OF EYES.", "INACTIVE INGREDIENT": "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 ACID, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT, RETINYL PALMITATE, TOCOPHEROL, TOCOPHERYL ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492).", "INDICATIONS AND USAGE": "To use: Squeeze tube and apply liberally with self-applicator tip.", "DOSAGE & ADMINISTRATION": "apply liberally", "OTC - ACTIVE INGREDIENT": "ACTIVE INGREDIENTS: OCTINOXATE, 4.0 % W/W AVOBENZONE, 3.0 % W/W", "OTC - KEEP OUT OF REACH OF CHILDREN": "KEEP OUT OF REACH OF CHILDREN."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:37.286550 · Updated: 2026-03-14T22:53:28.900881