KIDS SUNSCREEN SPF 50 WEGMANS- homosalate - 6.00% octinoxate - 7.50% octisalate - 5.00% octocrylene - 10.00% zinc oxide - 8.00% stick

Kids Sunscreen SPF 50 by

Drug Labeling and Warnings

Kids Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Wegman, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                         Purpose

Homosalate 6.0%....................................................Sunscreen
Octinoxate 7.5%......................................................Sunscreen
Octisalate 5.0%.......................................................Sunscreen
Octocrylene 10.0%..................................................Sunscreen
Zinc Oxide 8.0%......................................................Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn

INDICATIONS & USAGE

Uses helps prevent sunburn

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 product is 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
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 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
children under 6 months: Ask a doctor

Inactive ingredients

1,2-Hexanediol, Aloe Barbadensis Leaf Extract, C12-15 Alkyl
Benzoate, Caprylyl Glycol, Ceresin, Chamomilla Recutita
(Matricaria) Flower Extract, Copernicia Cerifera (Carnauba)
Wax, Dimethicone, Ethyl Macadamiate, Ethylhexyl Palmitate,
Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated
Polyisobutene, Hydrogenated Vegetable Oil, Lavandula
Angustifolia (Lavender) Extract, Octyldodecanol, Polyethylene,
Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sorbitan
Sesquioleate, Tocopheryl Acetate, Triethoxycaprylylsilane

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIDS SUNSCREEN SPF 50  WEGMANS
homosalate - 6.00% octinoxate - 7.50% octisalate - 5.00% octocrylene - 10.00% zinc oxide - 8.00% stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47124-338
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	6 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	10 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
1,2-Hexanediol (UNII: TR046Y3K1G)
Aloe (UNII: V5VD430YW9)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Caprylyl Glycol (UNII: 00YIU5438U)
Ceresin (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
Dimethicone (UNII: 92RU3N3Y1O)
Ethyl Macadamiate (UNII: ANA2NCS6V1)
Ethylhexyl Palmitate (UNII: 2865993309)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
Mineral Oil (UNII: T5L8T28FGP)
Octyldodecanol (UNII: 461N1O614Y)
ALMOND OIL (UNII: 66YXD4DKO9)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Triethoxycaprylylsilane (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47124-338-01	14.2 g in 1 TUBE; Type 0: Not a Combination Product	01/03/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/03/2013

Labeler - Wegman (059650069)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(47124-338) , label(47124-338)