EXEL CLARIFYING LINE SPF 50- octinoxate, octocrylene, oxybenzone, tatanium dioxide cream

Exel Clarifying Line by

Drug Labeling and Warnings

Exel Clarifying Line 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 7.5% ........ Sunscreen
Octocrylene 8% ........ Sunscreen

Oxybenzone 3% ........ Sunscreen

Titanium Dioxide 5% ........ Sunscreen

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

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.

DOSAGE & ADMINISTRATION

Directions

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Children under 6 month: 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 10 AM - 2 PMWear long-sleeved shirts, pants, hats, and sunglassesUse a water resistant sunscreen if swimming or sweating

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, BHT, Butyrospermum Parkii (shea butter) Extract, Calcium Disodium EDTA, Caprylic/Capric Triglyceride, Cetearyl Alcohol (and) Ceteareth-20, Cyclomethicone, Cyclopentasiloxane, Diethlyamino Hydroxybenzoyl Hexyl Benzoate, Dimethicone, DMDM Hydantoin, Ectoin, Fragrance (Parfum), Glyceryl Stearate SE, Hamamelis Virginiana (witch hazel) Extract, Iron Oxides (C.I. 77497/77492/77499), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium DNA, Tocopheryl Acetate, Water (Aqua), Xanthan Gum, Yeast Extract (saccharomyces cerevisiae extract)  

PRINCIPAL DISPLAY PANEL

Exel Clarifying Line
SPF 50
Broad Spectrum SPF 50

3.30 fl.oz / 100 ml

INGREDIENTS AND APPEARANCE

EXEL CLARIFYING LINE  SPF 50
octinoxate, octocrylene, oxybenzone, tatanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67623-001
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	8 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SHEANUT OIL (UNII: O88E196QRF)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ECTOINE (UNII: 7GXZ3858RY)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67623-001-02	1 in 1 PACKAGE	05/14/2015
1	NDC: 67623-001-01	100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/14/2015

Labeler - Biocosmetica Exel Argentina SRL (971813332)

Registrant - Biocosmetica Exel Argentina SRL (971813332)

Establishment
Name	Address	ID/FEI	Business Operations
Biocosmetica Exel Argentina SRL		971813332	manufacture(67623-001)