SPF 50 PLUS SUNSCREEN- titanium dioxide, octisalate, and zinc oxide lotion

SPF 50 plus Sunscreen by

Drug Labeling and Warnings

SPF 50 plus 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

Octisalate 5.0%, Titanium Dioxide 3.0%, Zinc Oxide 6.0%
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 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, butyloctyl salicylate, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, stearyl/octyldodecyl citrate crosspolymer, polyglyceryl-2 stearate, simmondsia chinensis (jojoba) seed oil1, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, glyceryl stearate, cetyl alcohol, cocos nucifera (coconut) oil1, glycerin1, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, butyrospermum parkii (shea) butter1, jojoba esters, stearyl alcohol, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, polyhydroxystearic acid, xanthan gum, silica, alumina, ethylhexylglycerin, trisodium ethylenediamine disuccinate, phenoxyethanol

1 Certified Organic Ingredient
Unless otherwise specified, product not labeled as organic

SPL UNCLASSIFIED SECTION

dist. by KAS direct, LLC
Westbury, NY 11590

PRINCIPAL DISPLAY PANEL - 177 mL Tube Label

50+
SPF

tear
free

water
resistant

babyganics

SPF 50+
sunscreen
lotion

broad spectrum SPF 50+
UVA + UVB protection
water resistant (80 minutes)
non-allergenic pediatrician
& dermatologist tested

formulated with: Zinc Oxide,
Octisalate, Titanium Dioxide*

formulated without: PABA
phthalates parabens
fragrances nano-particles

Discover which of our
ingredients are Certified
Organic on back panel.

6 FL OZ (177mL)

PRINCIPAL DISPLAY PANEL - 177 mL Tube Label

INGREDIENTS AND APPEARANCE

SPF 50 PLUS SUNSCREEN
titanium dioxide, octisalate, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-1000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	30 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	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK)
Polyglyceryl-2 Stearate (UNII: 253MC0P0YV)
CETYL ALCOHOL (UNII: 936JST6JCN)
Jojoba Oil (UNII: 724GKU717M)
Glyceryl Monostearate (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
Coconut Oil (UNII: Q9L0O73W7L)
Tomato Seed Oil (UNII: 7N87T9C06T)
Sunflower Oil (UNII: 3W1JG795YI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
Cranberry Seed Oil (UNII: 73KDS3BW5E)
Nigella Sativa Seed Oil (UNII: CS4U38E731)
Raspberry Seed Oil (UNII: 9S8867952A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
Shea Butter (UNII: K49155WL9Y)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Docosanol (UNII: 9G1OE216XY)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Aluminum Oxide (UNII: LMI26O6933)
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 59062-1000-2	59 mL in 1 TUBE; Type 0: Not a Combination Product	07/24/2017	12/31/2025
2	NDC: 59062-1000-6	177 mL in 1 TUBE; Type 0: Not a Combination Product	07/24/2017	12/31/2025
3	NDC: 59062-1000-8	236 mL in 1 TUBE; Type 0: Not a Combination Product	07/24/2017	12/31/2026
4	NDC: 59062-1000-1	354 mL in 1 TUBE; Type 0: Not a Combination Product	07/24/2017	12/31/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	07/24/2017	12/31/2026

Labeler - KAS Direct LLC dba BabyGanics (002764605)