RITE AID RENEWAL SUNSCREEN- ensulizole lotion 
RITE AID CORPORATION

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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DRUG FACTS

ACTIVE INGREDIENT

ENSULIZOLE  2.0%, OCTINOXATE  7.5%, OCTOCRYLENE  7.5%, ZINC OXIDE  1.9%

PURPOSE

SUNSCREEN

USES

TO HELP MOISTURIZE, RELIEVE AND PROTECT SKIN

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IF IRRITATION OR REDNESS DEVELOPS AND LASTS

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL IMMEDIATELY

DIRECTIONS

APPLY LIBERALLY ON FACE, NECK AND OTHER EXPOSED AREAS EVERY MORNING AFTER CLEANSING. PERFECT ALONE OR UNDER MAKEUP. FOR SUNSCREEN BENEFITS, APPLY PRIOR TO SUN EXPOSURE.

QUESTIONS OR COMMENTS

1-866-695-3030

INACTIVE INGREDIENTS

WATER, GLYCERIN,CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES, ISOHEXADECANE, BUTYLOCTYL SALICYLATE, CYCLOPENTASILOXANE, PEG-100 STEARATE, GLYCERYL STEARATE, CETEARYL ALCOHOL, TRIETHOXYCAPRYLSILANE, TRIETHANOLAMINE, BEHENYL ALCOHOL, SODIUM HYALURONATE, CYCLOHEXASILOXANE, CODIUM TOMENTOSUM, BHT, TOCOPHEROL, CALCIUM PENTOTHENATE, BISABOLOL, DICETYL PHOSPHATE, CETETH-10 PHOSPHATE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, TRIMETHYLOLPROPANE TRIETHYLHEXANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM ACRYLATES COPOLYMER, XANTHAN GUM, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, BUTYLPARABEN, IRON OXIDES

LABEL COPY

image of the label

RITE AID RENEWAL  SUNSCREEN
ensulizole lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.9 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TROLAMINE (UNII: 9O3K93S3TK)  
BEHENYL PHOSPHATE (UNII: 366D9UAY69)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
1,2-BUTANEDIOL (UNII: RUN0H01QEU)  
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
ANISACRIL (UNII: 5TB1FV429Z)  
GUAR GUM (UNII: E89I1637KE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-3410-250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/21/2011
Labeler - RITE AID CORPORATION (014578892)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 7/2011
Document Id: 960eece5-bd7b-4185-9456-a84039f26e05
Set id: e9d28e14-b847-4915-8620-2e9fd5eb6e04
Version: 1
Effective Time: 20110721
 
RITE AID CORPORATION