Label: OLOGY- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-3560-02 - Packager: WALGREEN COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 8, 2013
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- ACTIVE INGREDIENTS
- USE(S)
- WARNINGS
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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
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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
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INGREDIENTS AND APPEARANCE
OLOGY
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3560 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.0255 g in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.03 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-3560-02 57 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 04/05/2013 Labeler - WALGREEN COMPANY (008965063) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(0363-3560)
