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

CALIFORNIA NATUREL LIP BALM by

Drug Labeling and Warnings

CALIFORNIA NATUREL LIP BALM by is a Otc medication manufactured, distributed, or labeled by CALIFORNIA NATUREL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

TITANIUM DIOXIDE 1.8%

ZINC OXIDE 2%

PURPOSE

PURPOSE

SUNSCREEN

INDICATIONS & USAGE

USES

• HELPS PROTECT AGAINST SUNBURN AND CHAPPED LIPS

WARNINGS

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

DOSAGE & ADMINISTRATION

DIRECTIONS

• APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.8 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
KIWI SEED OIL (UNII: O70FWV3WPP)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL BENZOATE (UNII: 28ON9X7M1L)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SAFFLOWER OIL (UNII: 65UEH262IS)
YELLOW WAX (UNII: 2ZA36H0S2V)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
STRAWBERRY JUICE (UNII: U8NS58UGW0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOSTEARIC ACID (UNII: X33R8U0062)
LANOLIN (UNII: 7EV65EAW6H)
OLIVE OIL (UNII: 6UYK2W1W1E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)
CASTOR OIL (UNII: D5340Y2I9G)
SUCRALOSE (UNII: 96K6UQ3ZD4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LOWBUSH BLUEBERRY JUICE (UNII: 834067J0NY)
CRANBERRY JUICE (UNII: Y74M3X3345)

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

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

Labeler - CALIFORNIA NATUREL (079115834)