RITE AID RENEWAL SUNSCREEN- ensulizole lotion

RITE AID RENEWAL by

Drug Labeling and Warnings

RITE AID RENEWAL by is a Otc medication manufactured, distributed, or labeled by RITE AID CORPORATION, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

RITE AID RENEWAL  SUNSCREEN
ensulizole lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-3410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.9 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-3410-2	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/21/2011

Labeler - RITE AID CORPORATION (014578892)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture