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

ERBAORGANICS

SPF30
BROAD SPECTRUM SUNSCREEN

Completely natural water resistant (80 minutes)
sunscreen for children and adults.

EBO_Sunscreen_LBL_2oz_20120318

SUNSCREEN  SPF 30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43239-101
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:43239-101-1375 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/18/2012
Labeler - ERBAVIVA INC. (006459540)
Registrant - ERBAVIVA INC. (006459540)

Revised: 3/2012
Document Id: 65dba14a-31fa-4eef-8853-e9462219a832
Set id: 3312d786-1a83-4bba-8b57-077df75293fd
Version: 1
Effective Time: 20120318
 
ERBAVIVA INC.