EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS- octocrylene, octinoxate, octisalate, titanium dioxide, ensulizole cream

EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS by

Drug Labeling and Warnings

EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS by is a Otc medication manufactured, distributed, or labeled by Biocosmetica Exel Argentina SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients , purpose

Octocrylene 10%, sunscreen
Octinoxate 5%, sunscreen
Octisalate 5%, sunscreen
Titanium dioxide 5%, sunscreen
Ensulizole 4 %, 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.

Warnings

For external use only. Do not swallow.
If swallowed, get medical help or contact a Poison Control Center right away.
Do not use on damaged or broken skin.
When using this product: keep out of eyes. Rinse with water to remove .
Stop use and ask a doctor if rash occurs .
Keep out of reach of children .
This product is not formulated for use in children.

Directions

Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
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.
Children under 6 months of age: ask a doctor.

Inactive Ingredients

BISABOLOL, BUTYROSPERMUM PARKII BUTTER, CALCIUM DISODIUM EDTA, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, CARBOMER, CETEARETH-20, CETEARYL ALCOHOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, GLYCERYL STEARATE S.E., HYDROGENATED PHOSPHATIDYLCHOLINE, LINOLEIC ACID, PALMITOYL PENTAPEPTIDE-4, PHENOXYETHANOL, PHOSPHOLIPIDS, POLYPODIUM LEUCOTOMOS LEAF EXTRACT, POLYSORBATE 20, PROPANEDIOL, SODIUM ASCORBYL PHOSPHATE, SODIUM HYALURONATE, TOCOPHERYL ACETATE, WATER (AQUA), XANTHAN GUM

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

.

INDICATIONS & USAGE

.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS 
octocrylene, octinoxate, octisalate, titanium dioxide, ensulizole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67623-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	4 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LINOLEIC ACID (UNII: 9KJL21T0QJ)
WATER (UNII: 059QF0KO0R)
BISABOLOL (UNII: 24WE03BX2T)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
CALCIUM DISODIUM EDTA (UNII: 8U5D034955)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CETEARETH-20 (UNII: YRC528SWUY)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROGENATED SOYBEAN PHOSPHATIDYLCHOLINE (UNII: QHQ97HF0PY)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67623-004-01	1 in 1 CARTON	01/01/2025
1		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 Drug	M020	01/01/2025

Labeler - Biocosmetica Exel Argentina SRL (971813332)

Establishment
Name	Address	ID/FEI	Business Operations
Biocosmetica Exel Argentina SRL		971813332	manufacture(67623-004)