VITAMIN C GLOW-PROTECT SPF 30- octisalate, avobenzone, octinoxate, and octocrylene lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W), Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX), Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51), Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)

Available from:

Buth-Na-Bodhaige, Inc.,

INN (International Name):

Octisalate

Composition:

Octisalate 0.05 g in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- helps prevent sunburn.

Authorization status:

OTC monograph not final

Summary of Product characteristics

VITAMIN C GLOW-PROTECT SPF 30- OCTISALATE, AVOBENZONE, OCTINOXATE, AND
OCTOCRYLENE LOTION
BUTH-NA-BODHAIGE, INC.,
_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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VITAMIN C GLOW-PROTECT LOTION SPF 30
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Avobenzone (2.0% w/w)
Sunscreen
Octinoxate (7.5% w/w)
Sunscreen
Octisalate (5.0% w/w)
Sunscreen
Octocrylene (5.0% w/w)
Sunscreen
US ES
helps prevent sunburn.
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.
STOP USE AND ASK A DOCTOR IF
rash occurs.
KEEP OUT OF REACH OF CHILDREN. If product is swallowed, get medical
help or contact a Poison Control
Center right away.
DIRECTIONS
Apply liberally 15 minutes before sun exposure.
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 sun especially from 10 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats and sunglasses.
reapply this product at least every 2 hours.
use water resistant sunscreen if swimming or sweating.
children under 6 months of age: ask a doctor.
OTHER INFORMATION
protect the product in this container from excessive heat and direct
sun.
INACTIVE INGREDIENTS
Water, Isododecane, Hydrogenated Polydecene, Glycerin, Glyceryl
Stearate, Arachidyl Alcohol,
Caprylyl Glycol, Behenyl Alcohol, PEG-100 Stearate, Arachidyl
Glucoside, Cetyl Alcohol, Sesamum
Indicum (Sesame) Seed Oil, Tetrahexyldecyl Ascorbate, Phenoxyethanol,
Acrylamide/Ammonium
Acrylate Copolymer, Fragrance, Xanthan Gum, Polyisobutene,
Dimethicone, Myrciaria Dubia Fruit
Extract, Sorbic Acid, Disodium EDTA, Linalool, Limonene, Polysorbate
20, Sorbitan Isostearate,
Benzyl Benzoate, Citral, Potassi