SOFTLIPS WATERMELON- dimethicone, octinoxate, octisalate, oxybenzone stick

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)

Available from:

The Mentholatum Company

INN (International Name):

DIMETHICONE

Composition:

DIMETHICONE 20 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Dimethicone - Skin protectant Octinoxate - Sunscreen Octisalate - Sunscreen Oxybenzone - Sunscreen - helps prevent sunburn - temporarily protects chapped or cracked lips

Authorization status:

OTC monograph final

Summary of Product characteristics

SOFTLIPS WATERMELON- DIMETHICONE, OCTINOXATE, OCTISALATE,
OXYBENZONE STICK
THE MENTHOLATUM COMPANY
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Dimethicone 2%
Octinoxate 7.5%
Octisalate 3%
Oxybenzone 3%
PURPOSE
Dimethicone - Skin protectant
Octinoxate - Sunscreen
Octisalate - Sunscreen
Oxybenzone - Sunscreen
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
USES
helps prevent sunburn
temporarily protects chapped or cracked lips
WARNINGS
Skin Cancer/Skin Aging Alert: Spending time in the sun increased your
risk of skin cancer
and early skin aging. This product has been shown only to prevent
sunburn, not skin
cancer or early skin aging.
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
condition worsens
symptoms last more than 7 days or clear up and occur again within a
few days
DIRECTIONS
apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months: ask a doctor
INACTIVE INGREDIENTS
ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl
myristate, myristyl lactate,
flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT,
menthol, tocopheryl acetate
[vitamin E]
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
SOFTLIPS WATERMELON
dimethicone, octinoxate, octisalate, oxybenzone stick
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:10742-8476
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
DIMETHICONE
20 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
O