KENDO (as PLD) - OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN SPF-30 (71499-301) - DELIST

OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN by

Drug Labeling and Warnings

OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by KENDO HOLDINGS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN SPF 30- zinc oxide lotion 
KENDO HOLDINGS INC

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KENDO (as PLD) - OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN SPF-30 (71499-301) - DELIST

ACTIVE INGREDIENTS

ZINC OXIDE 16.32%

PURPOSE

SUNSCREEN

USES

• HELPS PREVENT SUNBURN
• IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

WARNINGS

FOR EXTERNAL USE ONLY.

DO NOT USE ON DAMAGED OR BROKEN SKIN.

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
• USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
• REAPPLY AT LEAST EVERY 2 HOURS.
• CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.
• SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
• LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M.
• WEAR LONG=SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

WATER, MEDIUM-CHAIN TRIGLYCERIDES, BUTYLOCTYL SALICYLATE, PROPANEDIOL, NIACINAMIDE, ALOE VERA LEAF, 1,2-HEXANEDIOL, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, SQUALANE, TETRAHEXYLDECYL ASCORBATE, ORANGE, ORANGE PEEL, LIMOSILACTOBACILLUS FERMENTUM, PANTHENOL, TOCOPHEROL, GLUCONOLACTONE,

GLYCERIN, JOJOBA ESTERS, SUNFLOWER OIL, GLYCERYL MONOSTEARATE, CETYL ALCOHOL, CALCIUM GLUCONATE, GLYCOL STEARATE, LECITHIN, SORBITAN MONOOLEATE, STARCH, HYDROXYACETOPHENONE, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, ISOHEXADECANE, XANTHAN GUM, CANOLA OIL, POLYSORBATE 80, POTASSIUM SORBATE, SODIUM BENZOATE, CITRIC ACID, OCTYLDODECANOL, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, CITRAL, LIMONENE, LINALOOL, TITANIUM DIOXIDE, IRON OXIDES

QUESTIONS?

OLEHENRIKSEN.COM

OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN  SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71499-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	16.32 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SQUALANE (UNII: GW89575KF9)
ORANGE (UNII: 5EVU04N5QU)
ORANGE PEEL (UNII: TI9T76XD44)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
PANTHENOL (UNII: WV9CM0O67Z)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CANOLA OIL (UNII: 331KBJ17RK)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCOL STEARATE (UNII: 0324G66D0E)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
FERROUS OXIDE (UNII: G7036X8B5H)
ISOHEXADECANE (UNII: 918X1OUF1E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TOCOPHEROL (UNII: R0ZB2556P8)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
CITRAL (UNII: T7EU0O9VPP)
NIACINAMIDE (UNII: 25X51I8RD4)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, TAPIOCA (UNII: 24SC3U704I)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71499-301-50	1 in 1 BOX	03/22/2023	03/22/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/22/2023	03/22/2023

Labeler - KENDO HOLDINGS INC (078489982)

Revised: 1/2024

Document Id: 09d1317f-8e88-b708-e063-6394a90a1ef5

34390-5

Set id: f7865528-48aa-bd8e-e053-6294a90a5ad3

Version: 3

Effective Time: 20240107