BIRDS GARDEN LIP BALM- octinoxate, octocrylene, octisalate, and oxybenzone stick

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Norwood Packaging Ltd.

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

BIRDS GARDEN LIP BALM CERULEAN WARBLER SPF 30- OCTINOXATE,
OCTOCRYLENE,
OCTISALATE, AND OXYBENZONE STICK
NORWOOD PACKAGING LTD.
_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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LIP BALM
ALOE & VITAMIN E
UVA / UVB PROTECTION
SPF 30
INGREDIENTS
MEDICINAL INGREDIENTS (W/W)
Octinoxate 7.5%, Octocrylene 7.0%, Octyl Salicylate 5.0%, Oxybenzone
5.0%.
NON-MEDICINAL INGREDIENTS
Petrolatum, Isopropyl Myristate, Paraffin, Candelilla Cera, Synthetic
Beeswax, Polyethylene, Cetyl
Alcohol, Lanolin, Isopropyl Lanolate, Oleyl Alcohol, Octyldodecanol,
Phenyl Trimethicone, Flavor,
Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Glycine Soja
(Soybean) Oil, Titanium Dioxide,
Methylparaben, Propylparaben, Silica, Saccharin, DEA-Oleth-3
Phosphate.
CONTAINS
Soy
Store between 15°C and 30°C
PRECAUTIONS
Avoid eye contact. For external use only.
Keep out of reach of children.
PRINCIPAL DISPLAY PANEL - 4 G CARTON
LIP BALM
ALOE & VITAMIN E
UVA / UVB PROTECTION
SPF 30
BIRDS GARDEN LIP BALM CERULEAN WARBLER SPF 30
octinoxate, octocrylene, octisalate, and oxybenzone stick
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:55143-0 0 9
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 CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)
OCTOCRYLENE
7 g in 10 0 g
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)
OCTISALATE
5 g in 10 0 g
O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)
OXYBENZONE
5 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PETRO LATUM (UNII: 4T6 H12BN9 U)
ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)
Norwood Packaging Ltd.
PARAFFIN (UNII: I9 O0 E3H2ZE)
CANDELILLA WAX (UNII: WL0 328 HX19 )
LO W DENSITY PO LYETHYLENE (UNII: