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

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California Naturel (as PLD) - LIP BALM (61547-101) - DELIST

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

KEEP OUT OF REACH OF CHILDREN.

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

140124-Outline-NOUVEAU_Dessin technique_LIPBALM Converti

CALIFORNIA NATUREL LIP BALM  SPF 8
titanium dioxide and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61547-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.8 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
KIWI SEED OIL (UNII: O70FWV3WPP)  
ALKYL (C12-15) 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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61547-101-511 in 1 BOX01/14/201412/31/2023
1NDC:61547-101-114.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/14/201412/31/2023
Labeler - CALIFORNIA NATUREL (079115834)

Revised: 4/2024
 
CALIFORNIA NATUREL