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

SPF 15 Protective Balm with UVA/UVB Sunscreens by

Drug Labeling and Warnings

SPF 15 Protective Balm with UVA/UVB Sunscreens by is a Otc medication manufactured, distributed, or labeled by Laboratoire Dr Renaud inc., Laboratoire Dr Renaud inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

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.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62499-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
LANOLIN (UNII: 7EV65EAW6H)
OCTYLDODECANOL (UNII: 461N1O614Y)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
ACETATE ION (UNII: 569DQM74SC)
LEVOMENOL (UNII: 24WE03BX2T)
PANTHENOL (UNII: WV9CM0O67Z)
ISOPROPYLPARABEN (UNII: A6EOX47QK0)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
CORN OIL (UNII: 8470G57WFM)
SUNFLOWER OIL (UNII: 3W1JG795YI)
T-BUTYLHYDROQUINONE (UNII: C12674942B)
GLYCERYL MONOOLEATE (UNII: 4PC054V79P)
BETA CAROTENE (UNII: 01YAE03M7J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	red (dark red)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62499-420-11	1 in 1 BOX
1	NDC: 62499-420-02	3.8 g in 1 CARTRIDGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/21/2011

Labeler - Laboratoire Dr Renaud inc. (202501565)

Registrant - Laboratoire Dr Renaud inc (202501565)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoire Dr Renaud inc		202501565	manufacture