ALOE SOOTHING MOISTURE SPF 15- 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

ALOE SOOTHING MOISTURE SPF 15- 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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ALOE SOOTHING MOISTURE LOTION SPF 15
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Avobenzone (3.0% w/w)
Sunscreen
Octinoxate (2.9% w/w)
Sunscreen
Octisalate (5.0% w/w)
Sunscreen
Octocrylene (2.2% 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 a 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, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Butylene
Glycol, Caprylic/Capric
Triglyceride, Sorbitol, Cetearyl Alcohol, Potassium Cetyl Phosphate,
Sesamum Indicum (Sesame) Seed
Oil, Dimethicone, Phenoxyethanol, Caprylyl Glycol, Panthenol,
Butyrospermum Parkii (Shea) Butter,
Aloe Barbadensis Leaf Juice Powder, Xanthan Gum, Carbomer, Bisabolol,
Potassium Sorbate,
Tetrasodium EDTA, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Pentylene
Glycol, BHT, Avena Sativa