Webb Candy Cherry Candy Cane Lip Balm

CHERRY CANDY CANE LIP BALM - octinoxate, oxybenzone, octisalate lipstick
Webb Candy

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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Active ingredients                                              Purpose
Octyl Methoxycinnamate 7.5 percent                 Sunscreen
Oxybenzone 3.0 percent                                   Sunscreen
Octyl Salicylate 2.0 percent                                 Sunscreen

Uses
- Helps prevent sunburn
- Higher SPF gives more sunburn protection
- Helps prevent and temporarily protects dry, chapped or windburned lips

Stop use and ask a doctor if
- rash or irritation develops and lasts
- condition worsens or does not improve within 7 days

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
- Apply liberally before sun exposure and as needed
- Children under 6 months of age, ask a doctor

Other Information
Sun alert. Limiting sun exposure, wearing protective
clothing, and using sunscreens may reduce the risks
of skin aging, skin cancer, and other harmful effects
of the sun.

Inactive Ingredients
POLYBUTENE, MINERAL OIL, ETHYLHEXYL PALMITATE,
PARAFFIN, CERESINE, MICROCRYSTALLINE WAX, BEES
WAX, FRAGRANCE, METHYLPARABEN, PROPYLPARABEN,
D AND C RED NO. 6 BA LAKE, D AND C RED NO. 27 AL LAKE,
TITANIUM DIOXIDE

For Add'l Info Call:
1.800.999.9322 or Visit
hiyamints.com or
webbcandy.com

CHERRY CANDY CANE LIP BALM
octinoxate, oxybenzone, octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49701-9001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PARAFFIN (UNII: I9O0E3H2ZE)
WAX, YELLOW (UNII: 2ZA36H0S2V)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
D&C RED NO. 6 (UNII: 481744AI4O)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49701-9001-1	425 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	09/11/2009

Labeler - Webb Candy (785835294)

Name	Address	ID/FEI	Business Operations
Establishment
Jinhua Garland Cosmetic Co., Ltd		546371824	manufacture