BE SMART GET PREPARED SUNSCREEN- sunscreen ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

Available from:

Total Resources International Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses - helps prevent sunburn - higher SPF gives more sunburn protection - for skin highly sensitive to sunburn Do not use • on damaged or broken skin. Stop use, ask a doctor if - rash occurs 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

BE SMART GET PREPARED SUNSCREEN- SUNSCREEN OINTMENT
TOTAL RESOURCES INTERNATIONAL INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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BE SMART GET PREPARED SUNSCREEN
ACTIVE INGREDIENT PURPOSE
Homosalate (6.0%)
Octinoxate (7.5%)
Octisalate (5.0%)
Oxybenzone (5.0%)....................Sunscreens
USES
helps prevent sunburn
higher SPF gives more sunburn protection
for skin highly sensitive to sunburn
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.
Stop use and ask a doctor if
rash occurs.
Do not use • on damaged or broken skin.
STOP USE, 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
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 INFORMATION
protect this product in this container from excessive heat and direct
sun
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
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
Total Resources International Inc.
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
OXYBENZONE
5 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)
HOMOSALATE
6 mg in 1 g
OCTINO