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

OI LIN SUNMILK SUNSCREEN SPF 25 by

Drug Labeling and Warnings

OI LIN SUNMILK SUNSCREEN SPF 25 by is a Otc medication manufactured, distributed, or labeled by Sunrider Manufacturing L.P.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: TITANIUM DIOXIDE 8.5%

INACTIVE INGREDIENT

INACTIVE INGREDIENT: WATER (DEIONIZED)

PURPOSE

USES: HELPS PREVENT SUNBURN.

INDICATIONS & USAGE

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.

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

MM1

MM2

MM3

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/27/2017	12/31/2022

Labeler - Sunrider Manufacturing L.P. (786951475)

Registrant - Sunrider Manufacturing L.P. (786951475)