BABYGANICS SUNSCREEN 50SPF- octinoxate, octisalate, and zinc oxide lotion

BabyGanics Sunscreen by

Drug Labeling and Warnings

BabyGanics Sunscreen by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.5%, Octisalate 5.0%, Zinc oxide 11.7%

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 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

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

water, glyceryl stearate, caprylic/capric triglyceride, propanediol, cyclopentasiloxane, stearyl/octadodecyl citrate crosspolymer, cetyl alcohol, cetearyl alcohol, polysorbate 60, dimethicone crosspolymer, glycerin, tocopheryl acetate, sodium stearoyl glutamate, beeswax, lauryl PEG/PPG-18/18 methicone, triethoxycaprylylsilane, xanthan gum, ethylhexylglycerin, disodium EDTA, potassium sorbate, phenoxyethanol, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 12 Single-Use Tube Bag

50+
SPF

tear
free

CLEAR WINDOW

water
resistant

babyganics®

mineral-based sunscreen

broad spectrum SPF 50+ ∙ UVA + UVB protection
water resistant (80 minutes) ∙ non-allergenic

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

+ NeoNourish® Natural Seed Oil Blend

12 SINGLE-USE TUBES ∙ 0.25 FL OZ (7mL) EACH

INGREDIENTS AND APPEARANCE

BABYGANICS SUNSCREEN   50SPF
octinoxate, octisalate, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-1238
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	117 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MONOSTEARYL CITRATE (UNII: YWW937R1QR)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
YELLOW WAX (UNII: 2ZA36H0S2V)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-1238-1	12 in 1 BAG	06/21/2013
1		7 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/21/2013

Labeler - KAS Direct LLC dba BabyGanics (002764605)