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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)

Available from:

Exelencia importers

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 7.5 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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. - Stop use and ask a doctor if rash occurs

Authorization status:

OTC monograph final

Summary of Product characteristics

CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL- OCTINOXATE, OCTOCRYLENE,
OXYBENZONE,
TITANIUM 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._
----------
EXEL CLARIFYING LINE
SPF 50
BROAD SPECTRUM SPF 50
ACTIVE INGREDIENTS PURPOSE
Octinoxate 7.5% .......... Sunscreen
Octocrylene 8% .......... Sunscreen
Oxybenzone 3% .......... Sunscreen
Titanium Dioxide 3% ...... Sunscreen
US ES
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 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 PM
Wear long-sleeved shirts, pants, hats, and sunglasses
Use a water resistanct sunscreen if swimming or sweating
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), Phen