OI LIN SUNMILK SUNSCREEN SPF 25- sunscreen, titanium dioxide emulsion
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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OIL LIN® SUNMILK SUNSCREEN SPF 25

ACTIVE INGREDIENT: TITANIUM DIOXIDE 8.5%

INACTIVE INGREDIENT: WATER (DEIONIZED)

USES: HELPS PREVENT SUNBURN.

RECOMMENDATION: APPPLY EVENLY TO ANY AREA OF THE BODY BEFORE SUN EXPOSURE TO PROVIDE MODERATE PROTECTION AGAINST SUNBURN. REAPPLY AS NEEDED OR AFTER PROLONGED PHYSICAL ACTIVITY OR SWIMMING. HIGHER SPF GIVES MORE SUNBURN PROTECTION. RETAINS SPF AFTER 40 MINUTES OF ACTIVITY IN THE WATER. 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.

MM1

MM2

MM3

OI LIN SUNMILK SUNSCREEN SPF 25
sunscreen, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62191-500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	85 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
ALANINE (UNII: OF5P57N2ZX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ARGININE (UNII: 94ZLA3W45F)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BETAINE (UNII: 3SCV180C9W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLUTAMIC ACID (UNII: 3KX376GY7L)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCINE (UNII: TE7660XO1C)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
isononyl isononanoate (UNII: S4V5BS6GCX)
LYSINE (UNII: K3Z4F929H6)
OATMEAL (UNII: 8PI54V663Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROLINE (UNII: 9DLQ4CIU6V)
SERINE (UNII: 452VLY9402)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SORBITOL (UNII: 506T60A25R)
SQUALANE (UNII: GW89575KF9)
THREONINE (UNII: 2ZD004190S)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62191-500-07	1 in 1 BOX	07/27/2017	12/31/2022
1		125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	07/27/2017	12/31/2022

Labeler - Sunrider Manufacturing L.P. (786951475)

Registrant - Sunrider Manufacturing L.P. (786951475)

Revised: 12/2019

Document Id: 1409014c-dd43-43a4-8eba-b51c4dbb4e2c

Set id: 8defb8bf-5a8d-47ff-88b5-ed3ede06b99d

Version: 5

Effective Time: 20191218

Sunrider Manufacturing L.P.