SUNSCREEN SPF 30- zinc oxide lotion 
ERBAVIVA INC.

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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SUNSCREEN

Active ingredient
ZINC OXIDE 20%

PURPOSE

SUNSCREEN

WARNINGS

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions
• apply liberally 15 minutes before sun exposure.
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours

Inactive ingredients: *Aloe barbadensis leaf juice, *anthemis nobilis (chamomile) flower oil, caprylic/capric triglycerides, *helianthus annuus (sunflower) seed oil, hydrogenated methyl abietate, *lavandula angustifolia (lavender) flower oil, magnesium sulfate, *olea europaea (olive) fruit oil, polyaminopropyl biguanide, polyglycerol-10 laurate, ricinus communis (castor) seed oil, *simmondsia chinensis (jojoba) seed oil, sorbitan stearate, tocopherol, water.

OTHER INFORMATION

ERBAVIVA

SUNSCREEN
SPF30


Completely natural broad spectrum
sunscreen, for children and adults.

EBV_2ozTubes_Sunscreen_NewFDA_m2b

SUNSCREEN  SPF 30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43239-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
CASTOR OIL (UNII: D5340Y2I9G)  
JOJOBA OIL (UNII: 724GKU717M)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL ABIETATE (UNII: 2F22LY70Q1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43239-201-1375 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/10/2012
Labeler - ERBAVIVA INC. (006459540)
Registrant - ERBAVIVA INC. (006459540)

Revised: 7/2012
Document Id: dc672b9a-24c6-40b7-95a7-de12e027adb4
Set id: d0d494f0-da15-482b-ac7d-2626764c06ef
Version: 1
Effective Time: 20120710
 
ERBAVIVA INC.