Lip & Cheek Treat Broad Spectrum Sunscreen Spf 40

Lip & Cheek Treat Broad Spectrum Sunscreen Spf 40
SPL v2
SPL
SPL Set ID 2bd43f78-2a3f-4072-a7e7-33e1848c6b55
Route
TOPICAL
Published
Effective Date 2016-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octinoxate (7.5 g) Octisalate (5 g)
Inactive Ingredients
Shea Butter Hydrogenated Polybutene (1300 Mw) Synthetic Wax (1200 Mw) Microcrystalline Wax Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Ceresin Silicon Dioxide Vinylpyrrolidone/hexadecene Copolymer Castor Oil Diisopropyl Sebacate Isodecyl Neopentanoate Lauryl Lactate Phenoxyethanol Diethylhexyl Syringylidenemalonate Titanium Dioxide D&c Red No. 7 Tocopherol Soybean Oil Benzoic Acid Polysilicone-15 Sunflower Oil Dehydroacetic Acid Cranberry Citric Acid Monohydrate Butylated Hydroxytoluene Olive Oil Avocado Oil Green Tea Leaf Water Calendula Officinalis Flower Salicylic Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-11-04

Description

Active Ingredients                           Purpose Avobenzone 3%, Homosalate 10%, Octinoxate 7.5%, Octisalate 5% ....... Sunscreen


Medication Information

Warnings and Precautions

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
  • If swallowed, get medical help or contact a Posion Control Center right away
  • If condition worsens or does not improve within 7 days, consult a doctor
Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

Apply liberally 15 minutes before sun exposure

  • Reapply liberally as oftenas necessary
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor

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.
  • Weare long-sleeved shirts, pants, hats, and sunglasses
Description

Active Ingredients                           Purpose Avobenzone 3%, Homosalate 10%, Octinoxate 7.5%, Octisalate 5% ....... Sunscreen

Section 50565-1

Keep out of reach of children

Section 51727-6

Butyrospermum Parkii (Shea) Butter, Hydrogenated Polyisobutene, Synthetic Beeswax, Microcrystalline Wax, Polyester-8, Ozokerite, Silica, VP/Hexadecene Copolymer, Ricinus Communis (Castor) Seed Oil, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Hydorgenated Vegetable Oil, Phenoxyethanol, Diethylhexyl Syringylidenemalonate, Titanium Dioxide, Red 7, Tocopherol, Glycine Soja (Soybean) Oil, Yellow 5 Lake, Benzoic Acid, Polysilicone-15, Helianthus Annuus (Sunflower) Seed Oil, Dehydoacetic Acid, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Citric Acid, BHT, Olea Europaea (Olive) Fruit Oil, Pesea Gratissima (Avocado) Oil, Camellia Sinensis Leaf Extract, Water, Calendula Officinalis Flower Extract, Salicylic Acid, Sodium Hydroxide

Section 51945-4

Perk Up

Lip & Cheek Treat

Broad Spectrum Sunscreen SPF 40

0.06 oz./ 4.5g

Section 55105-1

Uses

Helps prevent and temporarily protect chafed, chapped, cracked, or windburned skin and/or lips

  • Helps prevent subnurn
  • If use as directed with other sun pretction measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Section 55106-9

Active Ingredients                           Purpose

Avobenzone 3%, Homosalate 10%,

Octinoxate 7.5%, Octisalate 5% ....... Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

Apply liberally 15 minutes before sun exposure

  • Reapply liberally as oftenas necessary
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor

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.
  • Weare long-sleeved shirts, pants, hats, and sunglasses
Warnings and Precautions (34071-1)

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
  • If swallowed, get medical help or contact a Posion Control Center right away
  • If condition worsens or does not improve within 7 days, consult a doctor
Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Butyrospermum Parkii (Shea) Butter, Hydrogenated Polyisobutene, Synthetic Beeswax, Microcrystalline Wax, Polyester-8, Ozokerite, Silica, VP/Hexadecene Copolymer, Ricinus Communis (Castor) Seed Oil, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Hydorgenated Vegetable Oil, Phenoxyethanol, Diethylhexyl Syringylidenemalonate, Titanium Dioxide, Red 7, Tocopherol, Glycine Soja (Soybean) Oil, Yellow 5 Lake, Benzoic Acid, Polysilicone-15, Helianthus Annuus (Sunflower) Seed Oil, Dehydoacetic Acid, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Citric Acid, BHT, Olea Europaea (Olive) Fruit Oil, Pesea Gratissima (Avocado) Oil, Camellia Sinensis Leaf Extract, Water, Calendula Officinalis Flower Extract, Salicylic Acid, Sodium Hydroxide

Section 51945-4 (51945-4)

Perk Up

Lip & Cheek Treat

Broad Spectrum Sunscreen SPF 40

0.06 oz./ 4.5g

Section 55105-1 (55105-1)

Uses

Helps prevent and temporarily protect chafed, chapped, cracked, or windburned skin and/or lips

  • Helps prevent subnurn
  • If use as directed with other sun pretction measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Section 55106-9 (55106-9)

Active Ingredients                           Purpose

Avobenzone 3%, Homosalate 10%,

Octinoxate 7.5%, Octisalate 5% ....... Sunscreen


Advanced Ingredient Data


Raw Label Data

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