KIDS SPF 50PLUS SUNSCREEN CONTINUOUS- zinc oxide and octisalate spray

kids SPF 50plus sunscreen continuous by

Drug Labeling and Warnings

kids SPF 50plus sunscreen continuous 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%, Zinc oxide 15.0%
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.
- keep away from face to avoid breathing it
- do not puncture or incinerate. Contents under pressure.
- do not store at temperatures above 120° F
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
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- hold can 4-6 inches away from the skin to apply
- do not spray directly into face. Spray into hands then apply to face.
- do not apply in windy conditions
- use in a well-ventilated area
- 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-sleeve shirts, pants, hats, and sunglasses
Other information
- protect this product from excessive heat and direct sun
- may stain or damage some fabrics, materials or surfaces
Inactive ingredients

water, butyloctyl salicylate, C30-38 olefin/isopropyl maleate/MA copolymer, bentonite, caprylic/capric triglyceride, glycerin, olive oil polyglyceryl-6 esters, sodium stearoyl lactylate, cetearyl alcohol, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil 1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil 1, rubus idaeus (red raspberry) seed oil, phenethyl alcohol, glyceryl caprylate, xanthan gum, tocopherol

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

SPL UNCLASSIFIED SECTION

dist. by KAS direct, LLC
San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 170 g Can Label

new!

50+
SPF

babyganics

kids

SPF 50+ sunscreen
continuous spray

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

formulated with: Zinc Oxide,
Octisalate*

formulated without: Oxybenzone
Octinoxate nano-particles PABA
phthalates parabens fragrances

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

NET WT 6 OZ (170 g)

PRINCIPAL DISPLAY PANEL - 170 g Can Label

INGREDIENTS AND APPEARANCE

KIDS SPF 50PLUS SUNSCREEN CONTINUOUS
zinc oxide and octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-0175
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BENTONITE (UNII: A3N5ZCN45C)
Glycerin (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOPROPYL MALEATE (UNII: M86R5J916V)
MALEIC ANHYDRIDE (UNII: V5877ZJZ25)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TOCOPHEROL (UNII: R0ZB2556P8)
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)
C30-38 OLEFIN (UNII: 04DAD0KDZ0)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
RASPBERRY SEED OIL (UNII: 9S8867952A)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOMATO SEED OIL (UNII: 7N87T9C06T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 59062-0175-6	170 g in 1 CAN; Type 0: Not a Combination Product	12/15/2018	12/31/2025
2	NDC: 59062-0175-2	2 in 1 CELLO PACK	12/15/2018	12/31/2025
2		170 g in 1 CAN; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	12/15/2018	12/31/2025

Labeler - KAS Direct LLC dba BabyGanics (002764605)