SUNSCREEN SPF 30- zinc oxide lotion

SUNSCREEN by

Drug Labeling and Warnings

SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ERBAVIVA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
ZINC OXIDE 20%

PURPOSE

PURPOSE

SUNSCREEN

INDICATIONS & USAGE

• HELPS PREVENT SUNBURN

WARNINGS

WARNINGS

• FOR EXTERNAL USE ONLY

DO NOT USE

• DO NOT USE ON DAMAGED OR BROKEN SKIN.

WHEN USING

• KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE

• AND ASK A DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

OTHER SAFETY INFORMATION

• 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 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-sleeve shirts, pants, hats, and sunglasses

PEDIATRIC USE

• CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR
  

INACTIVE INGREDIENT

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.

STORAGE AND HANDLING

OTHER INFORMATION

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
  

PRINCIPAL DISPLAY PANEL

ERBAORGANICS

SPF30
BROAD SPECTRUM SUNSCREEN

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

INGREDIENTS AND APPEARANCE

SUNSCREEN  SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43239-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43239-101-13	75 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/18/2012

Labeler - ERBAVIVA INC. (006459540)

Registrant - ERBAVIVA INC. (006459540)