NDC | 62191-012-01, 62191-012-02 |
Set ID | 1ac04cf8-1c30-42a7-b053-317af39f5d74 |
Category | HUMAN OTC DRUG LABEL |
Packager | Sunrider Manufacturing L.P. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
-
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
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OI LIN SUNMILK SUNSCREEN SPF 25
sunscreen, titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62191-012 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) ALANINE (UNII: OF5P57N2ZX) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ARGININE (UNII: 94ZLA3W45F) BETAINE (UNII: 3SCV180C9W) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 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) GLYCINE (UNII: TE7660XO1C) HEXYL LAURATE (UNII: 4CG9F9W01Q) HYALURONATE SODIUM (UNII: YSE9PPT4TH) isononyl isononanoate (UNII: S4V5BS6GCX) LYSINE (UNII: K3Z4F929H6) OAT (UNII: Z6J799EAJK) 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:62191-012-01 15 g in 1 TUBE 2 NDC:62191-012-02 125 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/23/2009 Labeler - Sunrider Manufacturing L.P. (786951475) Registrant - Sunrider Manufacturing L.P. (786951475)