BABYGANICS SUNSCREEN 30SPF- titanium dioxide 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

Titanium dioxide 3.0%, Zinc oxide 3.0%

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 40 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, butyloctyl salicylate, cetearyl olivate, cocos nucifera (coconut) oil, sorbitan olivate, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetyl alcohol, stearyl/octadodecyl citrate crosspolymer, glycerin, ozokerite, simmondsia chinensis (jojoba) seed oil, butyrospermum parkii (shea) butter, theobroma cacao (cocoa) seed butter, jojoba esters, squalane, glyceryl caprylate, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, sucrose stearate, stearic acid, polyglyceryl-2 caprate, xanthan gum, polyhydroxystearic acid, silica, alumina, trisodium ethylenediamine disuccinate, ethylhexylglycerin, phenoxyethanol

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

30
SPF

tear
free

water
resistant

babyganics®

pure mineral
sunscreen

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

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

4 FL OZ (118mL)

INGREDIENTS AND APPEARANCE

BABYGANICS SUNSCREEN   30SPF
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-1227
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	30 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
COCONUT OIL (UNII: Q9L0O73W7L)
SORBITAN OLIVATE (UNII: MDL271E3GR)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETYL ALCOHOL (UNII: 936JST6JCN)
MONOSTEARYL CITRATE (UNII: YWW937R1QR)
GLYCERIN (UNII: PDC6A3C0OX)
CERESIN (UNII: Q1LS2UJO3A)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
DECYL JOJOBATE (UNII: ZL61O8TFZU)
SQUALANE (UNII: GW89575KF9)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SUCROSE STEARATE (UNII: 274KW0O50M)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-1227-1	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/21/2013

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)