SPF-30 BB- zinc oxide lotion

SPF-30 BB by

Drug Labeling and Warnings

SPF-30 BB by is a Otc medication manufactured, distributed, or labeled by ZION HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see other information) , decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

• For external use only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

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

Directions

Due to the nature of mineral formulations, separation may occur. Shake tube before use. Apply a smooth, even layer to face, neck and top of hands before sun exposure and as needed. Children under 6 months of age, ask a doctor.

Other 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 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.

Inactive Ingredients

Purified Water, Aloe Barbadensis Leaf Juice, Capric Caprylic, Triglycerides, Sorbitan Sesquioleate, Hydrogenated Castor Oil, Polyglycerol-10 Laurate, Magnesium Sulfate, Tetrahexyldecyl Ascorbate, Palmitoyl Tripeptide-3, Sunflower Oil, Jojoba Oil, Tocopherols, Hyaluronic Acid, Montmorillonite, Malakite Extract, Phenoxyethanol, Ethyl Hexyl Glycerin, Iron Oxides.

SPL UNCLASSIFIED SECTION

Manufactured by: Zion Health
P.O. Box 282249, San Francisco
CA 94128

PRINCIPAL DISPLAY PANEL - 110 mL Tube Label

zionhealth

ADAMA

BEAUTYBALM

AGE DEFENSE
MINERAL CREAM

Anti-Aging Minerals
Hydrating Formula

SPF 30 SUNSCREEN

2 fl. oz
60 ml

INGREDIENTS AND APPEARANCE

SPF-30 BB 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69090-0100
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONIC ACID (UNII: S270N0TRQY)
MONTMORILLONITE (UNII: A585MN1H2L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69090-0100-1	110 mL in 1 TUBE; Type 0: Not a Combination Product	01/20/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/20/2014

Labeler - ZION HEALTH (044641282)