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

Purpose

Sunscreen

Description

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


Medication Information

Warnings

For external use only

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

Purpose

Sunscreen

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

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

Description

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

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

Active Ingredients

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


Structured Label Content

Warnings

For external use only

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

Purpose

Sunscreen

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

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

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)

Active Ingredients (Active ingredients)

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


Advanced Ingredient Data


Raw Label Data

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