CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL- octinoxate, octocrylene, oxybenzone, titanium dioxide cream

Clarifying Line Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Clarifying Line Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Exelencia importers, Biocosmetica Exel Argentina SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients             Purpose

Octinoxate 7.5% ..........      Sunscreen

Octocrylene 8% ..........       Sunscreen

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

Titanium Dioxide 3% ......   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 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 PM
• Wear long-sleeved shirts, pants, hats, and sunglasses
• Use a water resistanct sunscreen if swimming or sweating 

INACTIVE INGREDIENT

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, BHT, Butyrospermun Parkii (Shea Butter) Etract, Calcium Disodium EDTA, Caprylic/Capric Triglyceride, Cetaryl Alcohol (and) Ceteareth-20, Cyclomethicone, Cyclopentasiloxane, Diethylamino Hydroxybenzoyl Hexyl Beanzoate, Dimethicone, DMDM Hydantoin, Ectoin, Fragrance (Parfum), Glyceryl Stearate SE, Hamamelis Virginiana (Witch Hazel) Extract, Iron Oxides (C.I. 77.491/77.492/77.499), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium DNA, Tocopheryl Acetate, Water (Aqua), Xanthan Gum, Yeast Extract (Saccharomyces Cerevisiae Extract) 

PRINCIPAL DISPLAY PANEL

SPF 50+

Broa Specturm SPF 50+

Designed to Apply "Exel Skin Lightening Program"

Contains Ectoin, Vitamin E Acetate

3.30 fl.oz    .      100 ml

INGREDIENTS AND APPEARANCE

CLARIFYING LINE BROAD SPECTRUM SPF 50  EXEL
octinoxate, octocrylene, oxybenzone, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53863-124
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	3 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: 53863-124-02	1 in 1 CARTON
1	NDC: 53863-124-01	100 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/23/2015

Labeler - Exelencia importers (147644335)

Registrant - Exelencia importers (147644335)

Establishment
Name	Address	ID/FEI	Business Operations
Biocosmetica Exel Argentina SRL		971813332	manufacture(53863-124)