SPF-45 SUNSCREEN description, usages, side effects, indications, overdosage, supplying and lots more!

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SPF-45 SUNSCREEN

J. A. Cosmetics U.S. INC
J. A. Cosmetics U.S. INC




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient:

TITANIUM DIOXIDE 23.3%

ZINC OXIDE 18.7%

Purpose

Purpose:

SUNSCREEN

Uses

Uses:

  • ​HELPS PREVENT SUNBURN

Warning:

  • For external use only
  • 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 HELP PREVENT SUNBURN, NOT SKIN CANCER OR SKIN AGING.
  • When Using This Product KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
  • Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN.

Directions:

  • APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE.
  • CHILDREN UNDER 6 MONTHS OF AGE; ASK A DOCTOR.
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.

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

  • LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M.-2 P.M.
  • WEAR LONG-SLEEVED SHIRT, PANTS, HATS AND SUNGLASSES.
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK DOCTOR.

  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.
  • STORE AT ROOM TEMPERATURE 15°C-30°C (59°F-86°F)

Inactive Ingredient:

MICA, TALC, BISMUTH OXYCHLORIDE, BORON NITRIDE, SILICA, VITIS VINEFERA (GRAPE) SEED EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, RETINYL PALMITATE (VA), TOCOPHERYL ACETATE (VE), MAGNESIUM ASCORBYL PHOSPHATE (VC), SODIUM DEHYDROACETATE

May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499), MAGNESIUM VIOLET (CI 77742)

QUESTIONS OR COMMENTS

1-855-353-7320

SPF-45 SUNSCREEN

SPF-45 SUNSCREEN

SPF-45 SUNSCREEN

TITANIUM DIOXIDE, ZINC OXIDE POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76354-107
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 23.3 g
Zinc Oxide Zinc oxide 18.7 1

Inactive Ingredients

Ingredient Name Strength
MICA
talc
BISMUTH OXYCHLORIDE
BORON NITRIDE
SILICON DIOXIDE
GRAPE
Aloe Vera Leaf
VITAMIN A PALMITATE
.ALPHA.-TOCOPHEROL ACETATE
Magnesium Ascorbyl Phosphate
SODIUM DEHYDROACETATE
ferric oxide red
MANGANESE VIOLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76354-107-31 10 in 1 CONTAINER
2 NDC:76354-107-51 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-05-12


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