CALIFORNIA NATUREL LIP BALM SPF 8- titanium dioxide and zinc oxide lipstick
CALIFORNIA NATUREL

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

TITANIUM DIOXIDE 1.8%

ZINC OXIDE 2%

PURPOSE

SUNSCREEN

USES

HELPS PROTECT AGAINST SUNBURN AND CHAPPED LIPS

WARNINGS

SKIN CANCER/SKIN AGING ALERT: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING; DO NOT USE ON DAMAGED OR BROKEN SKIN; STOP USE AND ASK A DOCTOR IF RASH OCCURS

DIRECTIONS

APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED

INACTIVE INGREDIENTS

ACTINIDIA CHINENSIS (KIWI) OIL, C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, CAPRYLIC/CAPRIC TRIGLYCERIDE, COPERNICIA CERIFERA (CARNAUBA) WAX, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, BEESWAX (CERA ALBA), ETHYLHEXYL STEARATE, FLAVOR (AROMA), FRAGARIA VESCA (STRAWBERRY) FRUIT EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, ISOSTEARIC ACID, LANOLIN, OLEA EUROPAEA (OLIVE) FRUIT OIL, POLYHYDROXYSTEARIC ACID, PUNICA GRANATUM EXTRACT, RICINUS COMMUNIS SEED OIL, SUCRALOSE, TOCOPHERYL ACETATE (VITAMIN E ACETATE), VACCINIUM ANGUSTIFOLIUM (BLUEBERRY) EXTRACT, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT

Outline-VF-CN-lipbalm-140109

CALIFORNIA NATUREL LIP BALM SPF 8
titanium dioxide and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:61547-101
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	1.8 g in 100 g
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
KIWI SEED OIL
C12-15 ALKYL BENZOATE
BUTYLOCTYL BENZOATE
SHEA BUTTER
MEDIUM-CHAIN TRIGLYCERIDES
CARNAUBA WAX
SAFFLOWER OIL
YELLOW WAX
ETHYLHEXYL STEARATE
STRAWBERRY JUICE
SUNFLOWER OIL
ISOSTEARIC ACID
LANOLIN
OLIVE OIL
POLYHYDROXYSTEARIC ACID (2300 MW)
PUNICA GRANATUM WHOLE
CASTOR OIL
SUCRALOSE
.ALPHA.-TOCOPHEROL ACETATE
LOWBUSH BLUEBERRY JUICE
CRANBERRY JUICE

#	Item Code	Package Description
Packaging
1	NDC:61547-101-51	1 in 1 BOX
1	NDC:61547-101-11	4.2 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/14/2014

Labeler - CALIFORNIA NATUREL (079115834)

Revised: 1/2014

Document Id: eba27bb5-a99c-4652-b1b3-62473ed7ace7

Set id: ab072d5e-2a09-41b1-b416-f961da842705

Version: 6

Effective Time: 20140117

CALIFORNIA NATUREL