ATTITUDE MINERAL SUNSCREEN SENSITIVE SKIN CARE LITTLE ONES- zinc oxide cream

ATTITUDE by

Drug Labeling and Warnings

ATTITUDE by is a Otc medication manufactured, distributed, or labeled by Bio Spectra, Fusion Solution inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS:

Active ingredient

Zinc oxide (20%)

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. If rash occurs, stop use and ask a doctor. When using this product keep out of eyes. Rinse with water to remove.

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: - At least every 2 hours - After 40 minutes of swimming or sweathing - Immediately after towel drying - 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 10am–2pm - Wear long-sleeved shirts, pants, hats, and sunglasses - Ask a doctor for use on children under 6 months of age.

Inactive or non-medicinal ingredients

Aqua, caprylic/capric triglyceride, cetearyl alcohol, cetearyl glucoside, avena sativa (oat) kernel flour, glyceryl isostearate, glyceryl stearate, C10-18 triglycerides, glycerin, polyhydroxystearic acid, ethylhexylglycerin, caprylyl glycol, xanthan gum, sodium gluconate.

Other Information

Store at temperatures below 90oF.

PRINCIPAL DISPLAY PANEL - 75 g Tube Label

BIO SPECTRA
ATTITUDE®
little ones

SENSITIVE SKIN CARE

WORRY-FREE
INGREDIENTS

SPF
30

100% MINERAL
SUNSCREEN
BROAD SPECTRUM (UVA/UVB), NON NANO

HYPOALLERGENIC FRAGRANCE-FREE

ACCEPTED
NATIONALECZEMA.ORG

NATIONAL
Eczema
ASSOCIATION

NPN 80047088

75 g / 2.6 OZ.

INGREDIENTS AND APPEARANCE

ATTITUDE   MINERAL SUNSCREEN SENSITIVE SKIN CARE LITTLE ONES
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61649-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
OATMEAL (UNII: 8PI54V663Y)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
GLYCERIN (UNII: PDC6A3C0OX)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM GLUCONATE (UNII: R6Q3791S76)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61649-003-75	1 in 1 CARTON	02/01/2017
1		75 g 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	02/01/2017

Labeler - Bio Spectra (201137051)

Establishment
Name	Address	ID/FEI	Business Operations
Fusion Solution inc		251948899	MANUFACTURE(61649-003)