Sun Protection Emulsion Face Spf 30

Sun Protection Emulsion Face Spf 30
SPL v2
SPL
SPL Set ID 688e7583-7e08-44f0-9af5-cec94678da25
Route
TOPICAL
Published
Effective Date 2011-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 mL) Homosalate (10 mL) Octisalate (2.5 mL) Octocrylene (2.4 mL) Oxybenzone (5 mL)
Inactive Ingredients
Hexyldecanol Dimethicone Aluminum Starch Octenylsuccinate Steareth-21 Cetyl Alcohol Silicon Dioxide Glycerin Aloe Vera Leaf Steareth-2 Edetate Disodium Sodium Hydroxide Squalane Potassium Sorbate Polysorbate 60 Medium-chain Triglycerides Sodium Lactate Caprylyl Glycol Alcohol Benzyl Alcohol Phenoxyethanol Chlorphenesin Sodium Benzoate Methylparaben Ethylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-02-14

Description

Active Ingredients            Purpose Avobenzone 3.0%            sunscreen Homosalate   10.0%         sunscreen Octisalate 2.6%                sunscreen octocrylene 2.4%              sunscreen Oxybenzone 5.0%            sunscreen


Medication Information

Warnings and Precautions

when using this product keep out of eyes.

rinse with water to remove.

Indications and Usage

Stop use and ask a doctor if rash or irritation develops and lasts.

Dosage and Administration

Apply daily after cleansing and toning .

Smooth over face and throat.

Apply evenly before sun exposure.

Reapply as needed or after towel drying, swimming or perspiring.

Description

Active Ingredients            Purpose Avobenzone 3.0%            sunscreen Homosalate   10.0%         sunscreen Octisalate 2.6%                sunscreen octocrylene 2.4%              sunscreen Oxybenzone 5.0%            sunscreen

Section 50565-1
Keep out of reach of children.



Do not use on infants under 6 months of age.

Section 51727-6

Water (Aqua), Caprylyl Methicone, Hexyldecanol, Dimethicone, Polyglyceryl-3 Methylglucose Distearate, Undercrylene Dimethicone, Aluminum Starch Octenylsuccinate, Steareth-21, Octyldodecyl Olivate, Cetyl Alcohol, Silica, Glycerin, Glycoproteins, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Sodium Hyaluronate, Corallina Officinalis Extract, Sea Water ( Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dimethoxydimethylindanone, sodium hydroxide, porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Pakmata Extract, Tocopheryl Acetate, Diethylhexyl Syringyldenemalonate, Pelvetia Canaliculata Extract, Polysorbate 60, Lecithin, Caprylic/ Capric Triglyceride, Sodium Lactate, Caprylyl Glycol, Alcohol, Benzyl Alcohol, Fragrance ( parfum), Phenoxyethanol, Chlorphenesin, Sodium Benzoate, Methylparaben, Ethylparaben, Propyparaben









Section 51945-4
Sun protection emulsion face SPF 30





125mL/ 4.2 FL. OZ.







Section 55105-1

- Helps prevent sunburn

- for skin that burns easily

-provides moderate protection against sunburn

-higher SPF gives more sunburn protection

Section 55106-9

Active Ingredients            Purpose

Avobenzone 3.0%            sunscreen

Homosalate   10.0%         sunscreen

Octisalate 2.6%                sunscreen

octocrylene 2.4%              sunscreen

Oxybenzone 5.0%            sunscreen




Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash or irritation develops and lasts.

Dosage and Administration (34068-7)

Apply daily after cleansing and toning .

Smooth over face and throat.

Apply evenly before sun exposure.

Reapply as needed or after towel drying, swimming or perspiring.

Warnings and Precautions (34071-1)

when using this product keep out of eyes.

rinse with water to remove.

Section 50565-1 (50565-1)
Keep out of reach of children.



Do not use on infants under 6 months of age.

Section 51727-6 (51727-6)

Water (Aqua), Caprylyl Methicone, Hexyldecanol, Dimethicone, Polyglyceryl-3 Methylglucose Distearate, Undercrylene Dimethicone, Aluminum Starch Octenylsuccinate, Steareth-21, Octyldodecyl Olivate, Cetyl Alcohol, Silica, Glycerin, Glycoproteins, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Sodium Hyaluronate, Corallina Officinalis Extract, Sea Water ( Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dimethoxydimethylindanone, sodium hydroxide, porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Pakmata Extract, Tocopheryl Acetate, Diethylhexyl Syringyldenemalonate, Pelvetia Canaliculata Extract, Polysorbate 60, Lecithin, Caprylic/ Capric Triglyceride, Sodium Lactate, Caprylyl Glycol, Alcohol, Benzyl Alcohol, Fragrance ( parfum), Phenoxyethanol, Chlorphenesin, Sodium Benzoate, Methylparaben, Ethylparaben, Propyparaben









Section 51945-4 (51945-4)
Sun protection emulsion face SPF 30





125mL/ 4.2 FL. OZ.







Section 55105-1 (55105-1)

- Helps prevent sunburn

- for skin that burns easily

-provides moderate protection against sunburn

-higher SPF gives more sunburn protection

Section 55106-9 (55106-9)

Active Ingredients            Purpose

Avobenzone 3.0%            sunscreen

Homosalate   10.0%         sunscreen

Octisalate 2.6%                sunscreen

octocrylene 2.4%              sunscreen

Oxybenzone 5.0%            sunscreen




Advanced Ingredient Data


Raw Label Data

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