Affinia Facial Moisturizer

Affinia Facial Moisturizer
SPL v6
SPL
SPL Set ID 97def817-8a7b-450d-acd3-74d2843bc92f
Route
TOPICAL
Published
Effective Date 2013-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (7.296 g) Octocrylene (6.08 g) Octisalate (3.648 g) Avobenzone (2.1888 g)
Inactive Ingredients
.alpha.-tocopherol Acetate Ammonium Acryloyldimethyltaurate/vp Copolymer Calcium Pantothenate Cetyl Alcohol Citric Acid Monohydrate Cocoa Butter Dimethicone Glycerin Glyceryl Monostearate Glyceryl Stearate Se Maltodextrin Mangifera Indica Seed Butter Methylisothiazolinone Niacinamide Peg-100 Stearate Phenoxyethanol Phenoxyethyl Caprylate Potassium Sorbate Pyridoxine Hydrochloride Sheanut Oil Silicon Dioxide Sodium Ascorbyl Phosphate Sodium Stearoyl Glutamate Trisodium Ethylenediamine Disuccinate Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-08-01

Description

Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 5%

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 34072-9

• may stain some fabrics

Section 44425-7

• protect this product from excessive heat and direct sun

• do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor is rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51945-4

Warnings

For external use only

Directions

For sunscreen use:

• apply smoothly on cleansed skin

• apply liberally 15 mintues before sun exposure

• 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 10a.m.-2p.m. • wear long-sleeve shirts, pants, hats, and sunglasses

Other Information

• for normal-to-dry skin

• dermatologist and allergy tested

Active Ingredients

Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 5%

Inactive Ingredients

Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua (Water/Eau), Butyrospermum Parkii (Shea Butter), Calcium Pantothenate, Cetyl Alcohol, Citric Acid, Dimethicone, Glycerin, Glyceryl Stearate, Maltodextrin, Mangifera Indica (Mango) Seed Butter, Methylisothiazolinone, Niacinamide, Parfum, PEG-100 Stearate, Phenoxyethanol, Phenoxyethyl Caprylate, Polyacrylate-15 (and) Polyacrylate-17, Potassium Sorbate, Pyridoxine HCL, Silica, Sodium Ascorbyl Phosphate, Sodium Starch Octenylsuccinate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Xanthan Gum


Structured Label Content

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 34072-9 (34072-9)

• may stain some fabrics

Section 44425-7 (44425-7)

• protect this product from excessive heat and direct sun

• do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor is rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

• apply smoothly on cleansed skin

• apply liberally 15 mintues before sun exposure

• 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 10a.m.-2p.m. • wear long-sleeve shirts, pants, hats, and sunglasses

Other Information (Other information)

• for normal-to-dry skin

• dermatologist and allergy tested

Active Ingredients (Active ingredients)

Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 5%

Inactive Ingredients (Inactive ingredients)

Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua (Water/Eau), Butyrospermum Parkii (Shea Butter), Calcium Pantothenate, Cetyl Alcohol, Citric Acid, Dimethicone, Glycerin, Glyceryl Stearate, Maltodextrin, Mangifera Indica (Mango) Seed Butter, Methylisothiazolinone, Niacinamide, Parfum, PEG-100 Stearate, Phenoxyethanol, Phenoxyethyl Caprylate, Polyacrylate-15 (and) Polyacrylate-17, Potassium Sorbate, Pyridoxine HCL, Silica, Sodium Ascorbyl Phosphate, Sodium Starch Octenylsuccinate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Xanthan Gum


Advanced Ingredient Data


Raw Label Data

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