Drug Facts

Active ingredients

Titanium Dioxide 2%.

Zinc Oxide 17%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Do not use

on damaged or broken skin

Stop use and ask a doctor

if rash occurs

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure • : • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Children under 6 months: Ask a doctor • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10a.m. - 2p.m. • Wear long-sleeved shirts, pants, hats and sunglasses

ReapplySun Protection Measures:

Other Information

•Protect the product in this container from excessive heat and direct sunlight • May stain some fabrics • You may report serious adverse reactions to: Report Reaction, LLC., PO Box 22, Plainsboro, NJ 08536-0222 Shake well. Rub in well.

Inactive Ingredients

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polysilicone-15, Tetrahexyldecyl Ascorbate (Vitamin C), Camellia Sinensis Leaf Extract (Green Tea), Punica Granatum Extract (Pomegranate), Vaccinium Macrocarpon (Cranberry) Fruit Extract, Tocopheryl Acetate (Vitamin E), Silica, Polyhydroxystearic Acid, EG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Iron Oxides (CI 77492, CI 77491, CI 77499).

Package Labeling:

Label

BASS PRO SHOPS BASS P SUNSCREEN BROAD SPECTRUM SPF 50
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14268-124
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	20 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	170 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
CRANBERRY (UNII: 0MVO31Q3QS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14268-124-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	04/19/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	04/19/2023

Labeler - ENGLEWOOD LAB, INC. (172198223)

Name	Address	ID/FEI	Business Operations
Establishment
ENGLEWOOD LAB, INC.		172198223	manufacture(14268-124) , label(14268-124)

Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50