OI LIN DEEP MOISTURE SUNSCREEN SPF 25 TINTED- sunscreen, titanium dioxide, zinc oxide lotion 
Sunrider Manufacturing L.P.

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.

----------

OI LIN DEEP MOISTURE SUNSCREEN SPF 25 TINTED

USES:  HELPS PREVENT SUNBURNS

RECOMMENDATION:  APPLY GENEROUSLY TO FACE BEFORE EXPOSURE TO SUN, AVOIDING CONTACT WITH EYES. REAPPLY TO EXPOSED AREAS AS NEEDED THROUGHOUT THE DAY

CHILDREN UNDER 6 MONTHS OF AGE:  CONSULT A DOCTOR BEFORE USE

WARNING:  FOR EXTERNAL USE ONLY, IF SWALLOWED, SEEK MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.  IF CONTACT WITH EYES OCCURS, RINSE THOROUGHLY WITH WATER.  DISCONTINUE USE AND CONSULT A DOCTOR IF PERSISTENT SIGNS OF IRRITATION OR RASH APPEAR

KEEP OUT OF REACH OF CHILDREN.

ACTIVE INGREDIENTS:

TITANIUM DIOXIDE 9.4%

ZINC OXIDE 3.9%

PUMPImage of label on 1.75 ounce pump

OI LIN DEEP MOISTURE SUNSCREEN SPF 25  TINTED
sunscreen, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE94 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 39 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CERAMIDE 3 (UNII: 4370DF050B)  
COMFREY ROOT (UNII: M9VVZ08EKQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYMBOPOGON SCHOENANTHUS LEAF (UNII: XF54B1Z2HF)  
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LEVOMENOL (UNII: 24WE03BX2T)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
MENTHA PULEGIUM (UNII: 5Q6Y7K4846)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENNYROYAL OIL (UNII: AK85U7Y3MV)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ROSEMARY (UNII: IJ67X351P9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62191-010-0150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/27/2009
Labeler - Sunrider Manufacturing L.P. (786951475)
Registrant - Sunrider Manufacturing L.P. (786951475)
Establishment
NameAddressID/FEIBusiness Operations
Sunrider Manufacturing L.P.786951475manufacture(62191-010)

Revised: 2/2013
Document Id: 62fdd9f8-ed38-4140-8185-93d23928a19d
Set id: b23cce9c-03b6-4168-9e4f-6bda149075ae
Version: 2
Effective Time: 20130213
 
Sunrider Manufacturing L.P.