SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS- octinoxate octisalate oxybenzone stick

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), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)

Available from:

Laboratoire Dr Renaud inc.

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 7.5 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS - OCTINOXATE OCTISALATE
OXYBENZONE STICK
LABORATOIRE DR RENAUD 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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DRUG FACTS
Octinoxate (Octyl Methoxycinnamate) à 7.5 % w/w, Octisalate (Octyl
Salicylate) à 3% w/w, Oxybenzone
à 3% w/w.
INACTIVE INGREDIENTS
RICINUS COMMUNIS (CASTOR) SEED OIL • LANOLIN OIL • OCTYLDODECANOL
• RED
PETROLATUM • ISOPROPYL PALMITATE • OZOKERITE • EUPHORBIA
CERIFERA
(CANDELILLA) WAX / CIRE DE CANDELILLA • BEESWAX / CIRE D’ABEILLE
• COPERNICA
CERIFERA (CARNAUBA) WAX / CIRE DE CARNAUBA • TOCOPHERYL ACETATE •
BISABOLOL • PANTHENOL • TOCOPHEROL • ZEA MAYS (CORN) OIL •
VEGETABLE OIL /
HUILE VEGETALE • GLYCERYL OLEATE • BETA-CAROTENE • PROPYLENE
GLYCOL •
TBHQ • CITRIC ACID • ISOPROPYLPARABEN • ISOBUTYLPARABEN •
BUTYLPARABEN •
Helps protect from sunburn.Formulated to minimize allergic risks.
Apply liberally and evenly 15 to 30 minutes before exposure to the
sun.Reapply every 2 hours and after
swimming perspiring heavily.
image of cartridge label
image of carton label
For external use only.Keep out of children. Avoid direct contact with
the eyes. Stop use if signs of rash
or irritation appear.Children under 6 months, ask doctor.
SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS
octinoxate octisalate oxybenzone stick
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 249 9 -420
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
7.5 g in 10 0 g
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)
OCTISALATE
3 g in 10 0 g
O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)
OXYBENZONE
3 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
RICINU