BabyGanics Sunscreen description, usages, side effects, indications, overdosage, supplying and lots more!

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BabyGanics Sunscreen

KAS Direct LLC dba BabyGanics

babyganics® Sunscreen Spray 30 SPF


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

Octinoxate 5.0%, Octisalate 4.0%, Zinc oxide 11.2%

Purpose

Sunscreen

BabyGanics 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 water to remove.

Stop use and 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:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months of age: 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

BabyGanics Sunscreen Other information

protect this product from excessive heat and direct sun

Inactive ingredients

water, caprylic/capric triglyceride, glycerin, vp/hexadecene copolymer, aloe barbadensis leaf juice, glyceryl stearate, hexaglyceryl polyricinoleate, polysorbate 80, phenethyl alcohol, glyceryl caprylate, sodium magnesium silicate, xanthan gum, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, squalane, citric acid, lecithin, polysorbate 60, sorbitan isostearate.

Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

30
SPF

tear
free

water
resistant

babyganics®

mineral-based
sunscreen spray

broad spectrum SPF 30
UVA + UVB protection
water resistant (80 minutes)
non-allergenic

no: PABA, phthalates, parabens,
fragrances or nano-particles

6 FL OZ (177mL)

040-12290-01

BabyGanics Sunscreen

BabyGanics Sunscreen

ZINC OXIDE, OCTINOXATE, and OCTISALATE SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59062-1229
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Zinc Oxide Zinc oxide 112 mg
OCTINOXATE OCTINOXATE 50 mg
OCTISALATE OCTISALATE 40 mg

Inactive Ingredients

Ingredient Name Strength
water
MEDIUM-CHAIN TRIGLYCERIDES
GLYCERIN
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)
Aloe Vera Leaf
GLYCERYL MONOSTEARATE
POLYGLYCERYL-6 DIOLEATE
polysorbate 80
PHENYLETHYL ALCOHOL
GLYCERYL CAPRYLATE
SODIUM MAGNESIUM FLUOROSILICATE
XANTHAN GUM
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)
SQUALANE
CITRIC ACID MONOHYDRATE
LECITHIN, SOYBEAN
POLYSORBATE 60
Sorbitan Isostearate

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59062-1229-1 177 in 1 BOTTLE, DISPENSING

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-06-21


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