OLOGY- titanium dioxide, zinc oxide lotion 
WALGREEN COMPANY

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 INGREDIENTS

TITANIUM DIOXIDE 2.55%, ZINC OXIDE 3.00%

PURPOSE

SUNSCREEN, SUNSCREEN

USE(S)

HELPS PREVENT SUNBURN. IF USED AS DIRECTED WITH OTHER SUN PROTECION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

WARNINGS

FOR EXTERNAL USE ONLY.

DO NOT USE

ON DAMAGED OR BROKEN SKIN.

WHEN USING THIS PRODUCT

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6 MONTHS: ASK A DOCTOR. SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS:

WATER (AQUA), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, CARTHAMUS TINCTORUS (SAFFLOWER) OLEOSOMES, RICINUS COMMUNIS (CASTOR) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL GLUCOSIDE, SUCROSE DISTEARATE, ROYAL JELLY, SUCROSE STEARATE, ACACIA SENEGAL GUM, CALENDULA OFFICINALIS FLOWER EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SYMPHYTUM OFFICINALE ROOT EXTRACT, XANTHAN GUM, LECITHIN, POLYHYDROXYSTEARIC ACID, STEARIC ACID, ALUMINA, CITRIC ACID, NATURAL FRAGRANCE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN.

LABEL COPY

IMAGE OF THE LABEL

OLOGY 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3560
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.0255 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
CASTOR OIL (UNII: D5340Y2I9G)  
COCONUT OIL (UNII: Q9L0O73W7L)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
SUCROSE DISTEARATE (UNII: 33X4X4B90S)  
ROYAL JELLY (UNII: L497I37F0C)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
ACACIA (UNII: 5C5403N26O)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
COMFREY ROOT (UNII: M9VVZ08EKQ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-3560-0257 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/05/2013
Labeler - WALGREEN COMPANY (008965063)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(0363-3560)

Revised: 4/2013
Document Id: 6abadab3-868b-43eb-968d-f0b2eea9ba10
Set id: 1cb6bf0f-b410-4da6-acbd-103da6e9c959
Version: 1
Effective Time: 20130408
 
WALGREEN COMPANY