BE SMART GET PREPARED SUNSCREEN- sunscreen ointment

Be Smart Get Prepared Sunscreen by

Drug Labeling and Warnings

Be Smart Get Prepared Sunscreen by is a Otc medication manufactured, distributed, or labeled by Total Resources International Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Homosalate (6.0%)

Octinoxate (7.5%)

Octisalate (5.0%)

Oxybenzone (5.0%)....................Sunscreens

PURPOSE

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• for skin highly sensitive to sunburn

WARNINGS

Skin cancer/skin aging alert: spending time in the sun increases your risk of skin cancer and early skin aging.This product has been shown only to prevent sunburn, not skin cancer or early aging skin.

For external use only.

ASK DOCTOR

Stop use and ask a doctor if

• rash occurs.

DO NOT USE

Do not use on damaged or broken skin.

STOP USE

Stop use, ask a doctor if

• rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

if swallowed, get medical help or contact a poison control center right away.

INDICATIONS & USAGE

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• children under 6 months: ask a doctor

OTHER SAFETY INFORMATION

Other Information

• protect this product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients

cetyl alcohol, ganex P-904, germaben II, petrolatum, polyoxyl 40 stearate, polysorbate 60, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BE SMART GET PREPARED SUNSCREEN 
sunscreen ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55550-950
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)
XANTHAN GUM (UNII: TTV12P4NEE)
POVIDONE K30 (UNII: U725QWY32X)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
EDETATE SODIUM (UNII: MP1J8420LU)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PETROLATUM (UNII: 4T6H12BN9U)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55550-950-02	1.5 g in 1 POUCH; Type 0: Not a Combination Product	01/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2023

Labeler - Total Resources International Inc. (790160535)