TRAVELER SPF15- octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)

Available from:

Island Company Lifestyle Products, LLC

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 50 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Octinoxate 5.0%         Sunscreen Octisalate 3.0%          Sunscreen Oxybenzone 2.0%       Sunscreen Avobenzone 2.0%       Sunscreen Octocrylene 1.5%       Sunscreen - Helps prevent sunburn - Higher SPF gives more sunburn protection - Rash or irritation develops and lasts

Authorization status:

OTC monograph final

Summary of Product characteristics

TRAVELER SPF15- OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE,
OCTOCRYLENE LOTION
ISLAND COMPANY LIFESTYLE PRODUCTS, LLC
_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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TRAVELER SPF15
ACTIVE INGREDIENTS PURPOSE
Octinoxate 5.0% Sunscreen
Octisalate 3.0% Sunscreen
Oxybenzone 2.0% Sunscreen
Avobenzone 2.0% Sunscreen
Octocrylene 1.5% Sunscreen
US ES
Helps prevent sunburn
Higher SPF gives more sunburn protection
WARNINGS
For external use only
Keep out of reach of children
WHEN USING THIS PRODUCT
Keep out of eyes. Rinse with water to remove
STOP USE AND ASK DOCTOR IF
Rash or irritation develops and lasts
DIRECTIONS
Apply liberally 20 minutes before sun exposure and as needed
For children under 6 months of age: Ask a doctor
OTHER INFORMATION
Sun alert: Limiting sun exposure, wearing protective clothing, and
using sunscreen may reduce the risk
of skin aging, skin cancer, and other harmful effects of the sun
INACTIVE INGREDIENTS
Water, Adipic Acid/Diethylene Gylcol Glycerin Crosspolymer,
Polycrylene, Isopropyl Myristate,
Fragrance, Propylene Glycol, Hydrogenated Polyisobutene, Polyethylene,
Aloe Barbadensis Leaf
Extract, Allantoin, Sodium Ascorbic Phosphate, Tocopheryl Acetate,
Retinyl Palmitate, Cetyl Alcohol,
Triethanolimine, C12-15 Alkyl Benzoate, Sorbitan Stearate,
Acrylates/c10-30 Alkyl Acrylate
Crosspolymer, Polysorbate 20, Carbomer, Carpylyl Glycol, Disodium
EDTA, Methylisothiazolinone
TRAVELER SPF15
octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:10 755-0 15
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
50 mg in 1 g
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)
OCTISALATE
30 mg in 1 g
AVO BENZO N