BODY GLOW SUNSCREEN description, usages, side effects, indications, overdosage, supplying and lots more!

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BODY GLOW SUNSCREEN

KATE SOMERVILLE SKINCARE, LLC


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

AVOBENZONE- 3%

HOMOSALATE, 7.5%

OCTISALALTE- 5%

OCTOCRYLENE, 2.5%

OXYBENZONE- 4%

PURPOSE

SUNSCREEN

USES

  • HELPS PREVENT SUNBURN.
  • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE ON DAMAGED OR BROKEN SKIN.

WHEN USING THIS PRODUCT, KEEP OUT OF EYES.

RINSE WITH WARM WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • 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.
  • SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:

      LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M.-2 P.M.

      WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

OTHER INFORMATION

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
  • YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PST.

INACTIVE INGREDIENTS

WATER/AQUA/EAU, NEOPENYL GLYCOL DIETHYLHEXANOATE, DIISOPROPYL DIMER DILINOLEATE, PROPANEDIOL, UNDECYLCRYLENE DIMETHICONE, MANGIFERA INDICA (MANGO) SEED BUTTER, BIS-PEG/PPG-20/5 PEG/PPG-20/5 DIMETHICONE, METHOXY PEG/PPG-25/4 DIMETHICONE, DIMETHICONE, BUTYROSPERMUM PARKII (SHEA) BUTTER, ETHYL METHICONE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, ETHYL FERULATE, POLYGLYCERYL-5 TRIOLEATE, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, DISODIUM URIDINE PHOSPHATE, NEOPENTYL GLYCOL DIETHYLHEXANOATE, SILICA, CAFFEINE, GLYCERYL STEARATE, CETEARYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHERYL ACETATE, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, CARBOMER, AMINOMETHYL PROPANOL, XANTHAN GUM, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, PHOSPHOLIPIDS, RETINYL PALMITATE, ASCORBYL PALMITATE, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, HYDROYLYZED CHONDRUS CRISPUS EXTRACT, SODIUM HYALURONATE, PHENOXYETHANOL, FRAGRANCE (PARFUM0, CITRONELLOL, GERANIOL, HEXYL CINNAMAL, LIMONENE, LINALOOL, MICA, TITANIUM DIOXIDE 9CI 77891), IRON OXIDES (77491)

BODY GLOW SUNSCREEN

BODY GLOW SUNSCREEN

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43479-205
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 3 g
HOMOSALATE Homosalate 7.5 g
OCTISALATE OCTISALATE 5 g
OCTOCRYLENE Octocrylene 2.5 g
OXYBENZONE OXYBENZONE 4 g

Inactive Ingredients

Ingredient Name Strength
water
NEOPENTYL GLYCOL DIETHYLHEXANOATE
Diisopropyl Dilinoleate
PROPANEDIOL
DIMETHICONE
Mangifera Indica Seed Butter
PEG/PPG-20/15 DIMETHICONE
PEG/PPG-25/25 DIMETHICONE
SHEA BUTTER
ETHYL METHICONE (8 MPA.S)
SUNFLOWER OIL
ETHYL FERULATE
POLYGLYCERYL-4 OLEATE
ROSEMARY
URIDINE MONOPHOSPHATE DISODIUM
SILICON DIOXIDE
CAFFEINE
GLYCERYL MONOSTEARATE
CETOSTEARYL ALCOHOL
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL ACETATE
CARRAGEENAN
carbomer 940
Aminomethylpropanol
XANTHAN GUM
ETHYLHEXYLGLYCERIN
EDETATE DISODIUM
EGG PHOSPHOLIPIDS
VITAMIN A PALMITATE
ASCORBYL PALMITATE
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
CHONDRUS CRISPUS CARRAGEENAN
HYALURONATE SODIUM
PHENOXYETHANOL
CITRONELLAL
GERANIOL
.ALPHA.-HEXYLCINNAMALDEHYDE
LIMONENE, (+)-
LINALOOL, (+/-)-
MICA
titanium dioxide
ferric oxide red

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43479-205-15 150 in 1 TUBE
2 NDC:43479-205-55 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-06-22


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