SILK LINE SILK DAY CREAM SPF 15- octinoxate, octocrylene, octisalate cream

Silk Line Silk Day Cream SPF 15 by

Drug Labeling and Warnings

Silk Line Silk Day Cream SPF 15 by is a Otc medication manufactured, distributed, or labeled by Biocosmetica Exel Argentina SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Octinoxate(Ethylhexyl methoxycinnamate) 7.5% Sunscreen

Octocrylene 7.0% Sunscreen

Octisalate (Ethylhexyl salicylate) 2.0 Sunscreen

PURPOSE

Uses

Helps prevent sunburn

Higher SPF gives more sunburn protection

If used as directed with other sun-protection measures ( see Directions) decreases the risk of skin cancer and early skin aging caused by de sun

KEEP OUT OF REACH OF CHILDREN

Do not use in children. Keep out of reach of children.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

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.

DOSAGE & ADMINISTRATION

Directions

• Apply and massage with a gentle circular motion in face and neck until completely absorbed 15 minutes before sun exposure.
• Reapply at least every 2 hours after towel drying, swimming or perspiring.
• Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher or other sun protection measures including:
• Limit time in the sun, especially between 10am-2pm
• Wear long sleeved shirts, pants, hats and sunglasses
• Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENT

Inactive ingredients

Purified Water (aqua), Cyclopentasiloxane, Glycerin1, Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Cyclomethicone, Dimethiconol, Hydrolyzed Silk, Ceteraryl Alcohol, Ceteareth-20, Yeast Extract, Sodium DNA, Aloe Barbadensis Leaf Extract, Panthenol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Imidazolinyl Urea, Butyrospermum Parkii Butter, Phenoxyethanol, Bisabolol, Tocopheryl Acetate, Calcium Disodium EDTA, DM DM Hydantoin, Polysorbate 20, Methylparaben, Fragrance (parfum), BHT, Propylparaben, Sodium Hyaluronate, Betacarotene

PRINCIPAL DISPLAY PANEL

Exel

Silk Line

Silk Day Cream SPF 15

with hydrolyzed silk proteins

Linea Seda

Crema De Dia FPS 15

Con hydrolizado de proteinas de seda

Biocosmetica Proffesional

1,69 fl Oz 50 ml

INGREDIENTS AND APPEARANCE

SILK LINE SILK DAY CREAM SPF 15 
octinoxate, octocrylene, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67623-610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
IMIDUREA (UNII: M629807ATL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PANTHENOL (UNII: WV9CM0O67Z)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BETA CAROTENE (UNII: 01YAE03M7J)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LEVOMENOL (UNII: 24WE03BX2T)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67623-610-17	50 mL in 1 BOX; Type 0: Not a Combination Product	10/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/26/2020

Labeler - Biocosmetica Exel Argentina SRL (971813332)

Establishment
Name	Address	ID/FEI	Business Operations
Biocosmetica Exel Argentina SRL		971813332	manufacture(67623-610)