Drug Facts

BAUME PRODIGIEUX LEVRES 01 NATURAL CRYSTAL NUTRI-PROTECTING LIP CARE SPF 15- octinoxate, avobenzone lipstick
LABORATOIRE NUXE

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

ACTIVE INGREDIENTS : OCTINOXATE (7.3%), AVOBENZONE (2.9%)

WARNINGS : Provides moderate protection against sunburn. Stop and ask a doctor if rash or irritation develops and lasts.

BAUME PRODIGIEUX LEVRES 01 NATURAL CRYSTAL NUTRI-PROTECTING LIP CARE SPF 15
octinoxate, avobenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67542-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.3 mL in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ALMOND OIL (UNII: 66YXD4DKO9)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SHEA BUTTER (UNII: K49155WL9Y)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
TRIHYDROXYPALMITAMIDOHYDROXYPROPYL MYRISTYL ETHER (UNII: NQ0RNU9701)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
C20-40 ACID (UNII: CKJ5537111)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67542-010-01	7 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	05/01/2006

Labeler - LABORATOIRE NUXE (260352379)