Sun Face Protector Broad Spectrum 50+

Sun Face Protector Broad Spectrum 50+
SPL v5
SPL
SPL Set ID 5647fe53-5adc-40b8-8055-f7de14c96029
Route
TOPICAL
Published
Effective Date 2014-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene Oxybenzone
Inactive Ingredients
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Allantoin Aluminum Starch Octenylsuccinate Arachidyl Alcohol Arachidyl Glucoside Arginine Oat Azadirachta Indica Bark Docosanol Levomenol Butylene Glycol Chlorphenesin Cyclomethicone 5 Edetate Disodium Ethylhexylglycerin Glyceryl Monostearate Licorice Sweet Potato Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Lauroyl Lysine Tea Tree Oil Methylisothiazolinone Mica Moringa Oleifera Bark Panthenol Peg-100 Stearate Peg-12 Dimethicone (300 Cst) Polysorbate 20 Silicon Dioxide Tagetes Erecta Flower .alpha.-tocopherol Acetate Chrysopogon Zizanioides Root Water Withania Somnifera Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-02-27

Description

Active ingredients       Purpose Avobenzone 3%        Sunscreen Homosalate 10%       Sunscreen Octisalate 5%            Sunscreen Octocrylene 10%        Sunscreen Oxybenzone 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

apply liberally 15 minutes 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

Description

Active ingredients       Purpose Avobenzone 3%        Sunscreen Homosalate 10%       Sunscreen Octisalate 5%            Sunscreen Octocrylene 10%        Sunscreen Oxybenzone 5%        Sunscreen

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Adipic Acid/Diglycol Crosspolymer, Allantoin, Alluminium Starch Octenylsuccinate, Arachidyl Alcohol,  Arachidyl Glucoside, Arginine, Avena Sativa (Oat) Kernel Extract, Azadirachta Indica Extract, Behenyl Alcohol, Bisabolol, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Dimethicone Copolyol, Disodium EDTA, Ethoxylated Castor Oil, Ethylhexyglycerin, Fragrance/Parfum, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Ipomoea Batatas Tuber Extract, Iron Oxides/CI 77491/CI 77492/CI 77499, Lauroyl Lysine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Mica, Moringa Oliefera Extract, Panthenol, PEG-100 Stearate, PEG-12 Dimethicone, Polysorbate 20, Silica, Styrene/Acrylates Copolymer, Tagetus Erecta (African Marigold) Extract, Tocopheryl Acetate, Vetivera Zinzanoids (Khus Root) Extract, Water/Aqua, Withania Somnifera (Winter Cherry) Extract

Section 51945-4

Jafra Sun Face Protector Sunscreen broad spectrum SPF 50+



50 ml 1.7 FL OZ (US)

Section 55105-1

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 55106-9

Active ingredients       Purpose

Avobenzone 3%        Sunscreen

Homosalate 10%       Sunscreen

Octisalate 5%            Sunscreen

Octocrylene 10%        Sunscreen

Oxybenzone 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

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

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Adipic Acid/Diglycol Crosspolymer, Allantoin, Alluminium Starch Octenylsuccinate, Arachidyl Alcohol,  Arachidyl Glucoside, Arginine, Avena Sativa (Oat) Kernel Extract, Azadirachta Indica Extract, Behenyl Alcohol, Bisabolol, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Dimethicone Copolyol, Disodium EDTA, Ethoxylated Castor Oil, Ethylhexyglycerin, Fragrance/Parfum, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Ipomoea Batatas Tuber Extract, Iron Oxides/CI 77491/CI 77492/CI 77499, Lauroyl Lysine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Mica, Moringa Oliefera Extract, Panthenol, PEG-100 Stearate, PEG-12 Dimethicone, Polysorbate 20, Silica, Styrene/Acrylates Copolymer, Tagetus Erecta (African Marigold) Extract, Tocopheryl Acetate, Vetivera Zinzanoids (Khus Root) Extract, Water/Aqua, Withania Somnifera (Winter Cherry) Extract

Section 51945-4 (51945-4)

Jafra Sun Face Protector Sunscreen broad spectrum SPF 50+



50 ml 1.7 FL OZ (US)

Section 55105-1 (55105-1)

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 55106-9 (55106-9)

Active ingredients       Purpose

Avobenzone 3%        Sunscreen

Homosalate 10%       Sunscreen

Octisalate 5%            Sunscreen

Octocrylene 10%        Sunscreen

Oxybenzone 5%        Sunscreen


Advanced Ingredient Data


Raw Label Data

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