OI LIN DEEP MOISTURE SUNSCREEN SPF 25 - 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.

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OI LIN DEEP MOISTURE SUNSCREEN SPF 25

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%

MM1

MM1

MM2

MM2

MM3

MM3

MM4

MM4
OI LIN DEEP MOISTURE SUNSCREEN SPF 25  
sunscreen, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-021
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 OXIDE39 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CERAMIDE 3 (UNII: 4370DF050B)  
CHAMOMILE (UNII: FGL3685T2X)  
COMFREY ROOT (UNII: M9VVZ08EKQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLDECANOL (UNII: 151Z7P1317)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
LEVOMENOL (UNII: 24WE03BX2T)  
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
MENTHA PULEGIUM (UNII: 5Q6Y7K4846)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
OAT (UNII: Z6J799EAJK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PLANTAGO OVATA SEED (UNII: UD50RBY30F)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ROSEMARY (UNII: IJ67X351P9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
THYME (UNII: CW657OBU4N)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containBROWN IRON OXIDE (UNII: 1N032N7MFO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62191-021-051 in 1 BOX08/01/201712/31/2022
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/201712/31/2022
Labeler - Sunrider Manufacturing L.P. (786951475)
Registrant - Sunrider Manufacturing L.P. (786951475)
Establishment
NameAddressID/FEIBusiness Operations
Sunrider Manufacturing L.P.786951475manufacture(62191-021)

Revised: 12/2019
Document Id: 6b26ee28-a4aa-44bb-9227-f272879c5652
Set id: 1ca30ae5-9998-45c3-a354-a9f3a554c128
Version: 6
Effective Time: 20191218
 
Sunrider Manufacturing L.P.