SEPHORA ROUGE BALM SUNSCREEN SPF20 B06-SOFT RED- octinoxate, octisalate, titanium dioxide lipstick

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)

Available from:

S+

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- Helps protect against sunburn.

Authorization status:

OTC monograph final

Summary of Product characteristics

SEPHORA ROUGE BALM SUNSCREEN SPF20 B06-SOFT RED- OCTINOXATE,
OCTISALATE,
TITANIUM DIOXIDE LIPSTICK
S+
_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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SEPHORA ROUGE BALM SUNSCREEN SPF20 B06-SOFT RED
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Octinoxate 7.125%
Octisalate 3%
Titanium dioxide 1.83%
_PURPOSE_
Sunscreen
_USE_
Helps protect against sunburn.
_WARNINGS_
SKING 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 help prevent sunburn,
NOT skin cancer or early skin
aging.
DO NOT USE
on damaged or broken skin
STOP USE AND ASK A DOCTOR IF
rash occurs
_DIRECTIONS_
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
_OTHER INFORMATION_
Protect the product in this container from excessive heat and direct
sun
_INACTIVE INGREDIENTS_
DIISOSTEARYL MALATE, OCTYLDODECANOL, ISOSTEARYL ISOSTEARATE,
POLYBUTENE, POLYETHYLENE, MICROCRYSTALLINE WAX,
SYNTHETIC BEESWAX, POLYGLYCERYL-3 DIISOSTEARATE, DIPENTAERYTHRITYL
HEXAHYDROXYSTEARATE, DICALCIUM PHOSPHATE, MICA,
DISTEARDIMONIUM HECTORITE, ALCOHOL, SILICA, FRAGRANCE (PARFUM),
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,
ALUMINUM HYDROXIDE, WATER (AQUA), TOCOPHEROL ACETATE, CITRUS JUNOS
PEEL
EXTRACT, ETHYLHEXYL PALMITATE, SILICA DIMETHYL SILYLATE, BUTYLENE
GLYCOL, CAPRYLYL GLYCOL, PHENOXYETHANOL, SODIUM HYALURONATE, HEXYLENE
GLYCOL, RED 7 LAKE,RED 6, YELLOW 6 LAKE
SEPHORA ROUGE BALM SUNSCREEN SPF20 B06-SOFT RED
octinoxate, octisalate, titanium dioxide lipstick
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:31720 -50 5
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
7.125 mg in 1 g
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALAT