RAYITO DE SOL SUNSCREEN SPF 18- octisalate oxybenzone padimate o cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W), Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y), Padimate O (UNII: Z11006CMUZ) (Padimate O - UNII:Z11006CMUZ)

Available from:

Siscom de Argentina SA

INN (International Name):

Octisalate

Composition:

Octisalate 2.8 g in 70 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Sunscreen Sunscreen Sunscreen - Helps prevent sunburn. - Higher SPF gives more sunburn protection. - Provides moderate protection against sunburn. - rash or irritation develops and lasts

Authorization status:

OTC monograph final

Summary of Product characteristics

RAYITO DE SOL SUNSCREEN SPF 18 - OCTISALATE OXYBENZONE PADIMATE O
CREAM
SISCOM DE ARGENTINA SA
_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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RAYITO DE SOL SUNSCREEN SPF 18
ACTIVE INGREDIENT
Octisalate 4%
Oxybenzone 6%
Padimate O 6%
PURPOS E
Sunscreen
Sunscreen
Sunscreen
US ES
Helps prevent sunburn.
Higher SPF gives more sunburn protection.
Provides moderate protection against sunburn.
WARNINGS
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT
do not use in or near the eyes
if it gets into eyes, rinse thoroughly with water
STOP USE AND ASK A DOCTOR IF
rash or irritation develops and lasts
SIDE EFFECT OCCUR. YOU MAY REPORT SIDE EFFECT TO FDA AT 1-800-FDA-1088
IF SWALLOWED, SEEK MEDICAL ATTENTION OR CONTACT A POISON CONTROL
CENTER IMMEDIATELY.
KEEP OUT OF THE REACH OF CHILDREN.
DIRECTIONS
Apply generously 15 minutes before sun exposure.
Children under six months of age: ask a doctor.
Reapply every 2 hours or after swimming or sweating or anytime after
towelling
OTHER INFORMATION
moderate sun protection product
SUN ALERT: limiting sun exposure, wearing protective clothing, and
using sunscreens may reduce the
risk of skin aging, skin cancer and other harmful effects of the sun.
may stain clothing when freshly applied. Avoid contact with fabric or
if fabric contact, launder
within the hour
INACTIVE INGREDIENTS
Mineral Oil, Petrolatum, Propylene Glycol, Ceresin, Paraffin, CI 77492
(and) CI 77491 (and) CI 77499,
Zinc Stearate, Beeswax, Fragrance, Propylparaben, Benzyl Salicylate,
Benzyl Alcohol,
Hydroxycitronellal, Linalool, Coumarin, Citronellol, Geraniol,
Eugenol, Amyl Cinnamal, Isoeugenol.
QUESTIONS OR COMMENTS?
if you are in United States
[phone]
PRINCIPAL DISPLAY PANEL
Rayito de Sol
Sunscreen SPF 18
70 g/2.4oz
RAYITO DE SOL SUNSCREEN SPF 18
octisalate oxybenzone padimate o cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOU