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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Exel Clarifying Line SPF 50

Active Ingredient ........ Purpose

Octinoxate 7.5% ........ Sunscreen
Octocrylene 8% ........ Sunscreen

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

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

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

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.

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

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)  

Exel Clarifying Line

SPF 50

Broad Spectrum SPF 50

3.30 fl.oz / 100 ml

PA-0687-ENSP-0720

PM-0867-ENSP-0720a

EXEL CLARIFYING LINE   SPF 50
octinoxate, octocrylene, oxybenzone, tatanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53863-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53863-125-021 in 1 PACKAGE05/14/2015
1NDC:53863-125-01100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/14/2015
Labeler - Exelencia importers (147644335)
Establishment
NameAddressID/FEIBusiness Operations
Biocosmetica Exel Argentina SRL971813332manufacture(53863-125)

Revised: 4/2023
Document Id: f9257df8-c7c4-984e-e053-6294a90ab51e
Set id: 0d6d4098-4121-477e-b404-3ab18628ed68
Version: 7
Effective Time: 20230412
 
Exelencia importers