NON-NANO SUNSCREEN SPF 40- zinc oxide lotion

NON-NANO SUNSCREEN by

Drug Labeling and Warnings

NON-NANO SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ProCaps Laboratories, Inc., Thibiant International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 17.5%

PURPOSE

Sunscreen

USE

• For external use only
• Do not use on damaged or broken skin
• When using this product keep out of eyes. Rinse with water to remove.
• Stop use and ask a doctor if rash occurs.
• Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

DIRECTIONS

• For sunscreen use
• apply liberally and evenly 15minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months of age: Ask a doctor.
• Sun Protection Measures: Spending time in the sun increasesyour 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 measuresincluding
• limit time in the sun, especially from 10 a.m.–2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses.

OTHER INFORMATION

• protect the product in this container from excessive heat and direct sun
• may stain some fabrics

QUESTIONS?

CALL 800.800.1200
www.ProCapsLabs.com

INACTIVE INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Silica, Coco-Glucoside, Microcrystalline Cellulose, Glycerin, Pyrus Malus (Apple) Fruit Extract, Cocoyl Proline, Humulus Lupulus (Hops) Extract, Isostearic Acid, Phenylpropanol, Polyhydroxystearic Acid, Xanthan Gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NON-NANO SUNSCREEN  SPF 40
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72879-505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	17.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
JOJOBA OIL (UNII: 724GKU717M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GLYCERIN (UNII: PDC6A3C0OX)
APPLE (UNII: B423VGH5S9)
COCOYL PROLINE (UNII: 0IH06971TF)
HOPS (UNII: 01G73H6H83)
ISOSTEARIC ACID (UNII: X33R8U0062)
PHENYLPROPANOL (UNII: 0F897O3O4M)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72879-505-02	1 in 1 BOX	03/29/2019
1		59 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 72879-505-04	1 in 1 BOX	03/29/2019
2		118 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 72879-505-06	1 in 1 BOX	03/29/2019
3		177 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/29/2019

Labeler - ProCaps Laboratories, Inc. (144872652)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	manufacture(72879-505)