PUBLIC GOODS- titanium dioxide, zinc oxide cream
Emilia Cosmetics Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Public Goods

Active ingredients

Titanium Dioxide, 7.6%

Zinc Oxide, 4.0%

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 at least every 2 hours

•use water resistant sunscreen if swimming or sweating

•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, hatsand sunglasses.

Other information •protect product in this container from excessive heat and direct sun

Inactive ingredients water, caprylic/capric triglyceride, sesamum

indicum (sesame) seed oil, helianthus annuus (sunflower) seed oil,

glycerin, coco-glucoside, coconut alcohol, ricinus communis (castor)

oil, simmondsia chinensis (jojoba) seed oil, butyrosperum parkii

(shea) butter, microcrystalline cellulose, cellulose gum, arachidyl

alcohol, behenyl alcohol, arachidyl glucoside, phenoxyethanol,

ethylhexylglycerin, xantham gum, PEG-40 stearate,

trimethoxycarpylylsilane, allantoin,tocopheryl acetate (vitamin E),

panthenol (pro-vitamin B5), bisabolol, hippophae rhammnioides oil,

echinacea purpurot extract, avena sativa (oat) extract, chamomilla

recutita (matricaria) flower extract, tilia vulgaris flower extract,

melissa officinalis leaf extract, aspalathus linearis leaf extract

Questions or comments? (855) 506-6742

label

PUBLIC GOODS
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43219-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	18 g in 236 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9.5 g in 236 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SESAME OIL (UNII: QX10HYY4QV)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
CASTOR OIL (UNII: D5340Y2I9G)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG-40 STEARATE (UNII: ECU18C66Q7)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
LEVOMENOL (UNII: 24WE03BX2T)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)
OAT BRAN (UNII: KQX236OK4U)
CHAMOMILE (UNII: FGL3685T2X)
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)
MELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43219-008-50	236 mL in 1 TUBE; Type 0: Not a Combination Product	02/04/2018	04/30/2021
2	NDC:43219-008-03	124 mL in 1 TUBE; Type 0: Not a Combination Product	06/20/2018	04/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/04/2018	04/30/2021

Labeler - Emilia Cosmetics Ltd (600076624)

Revised: 6/2023

Document Id: fe530be3-7718-b477-e053-6394a90a4e04

Set id: fde1e41f-142b-49b2-9eae-bdda5cd098f2

Version: 7

Effective Time: 20230617

Emilia Cosmetics Ltd