UberZinc by Synergie Skin UberZinc

UberZinc by

Drug Labeling and Warnings

UberZinc by is a Otc medication manufactured, distributed, or labeled by Synergie Skin. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UBERZINC- zinc oxide cream 
Synergie Skin

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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UberZinc

Drug facts

Active Ingredient

Zinc Oxide 21%

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 Poison Control Centre right away.

Directions

• For sunscreen use:
• Apply liberally and evenly 15 minutes before use exposure.
• 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.
• reapply at least every two hours.
• use a water-resistant sunscreen if swimming or sweating.
• children under 6 months of age: Ask a doctor

Other information

• protect the product in this container from excessive heat and directed sun

Inactive ingredients

Water, caprylic/capric triglyceride, glycerin, isoamyl laurate, methylpropanediol, cetearyl olivate, cetearyl alcohol, sorbitan olivate, orange peel oil, meadowfoam seed oil, macadamia seed oil, jojoba seed oil, hydrolyzed tomato skin, tocopherol, caprylyl glycol, ceteareth 20, guar gum, green tea leaf extract, sweet almond oil, sunflower seed oil, safflower seed oil, rosehip fruit oil, evening primrose oil, olive fruit oil, calendula flower extract, chamomile flower oil, olive leaf extract, xanthan gum, soybean oil, phenylpropanol, citric acid, sodium benzoate, potassium sorbate, sodium phytate, alcohol, sodium chloride, sodium hydroxide, citral, d-limonene, linalool

Package Labeling:

UBERZINC 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81475-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	210 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN OLIVATE (UNII: MDL271E3GR)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MACADAMIA SEED OIL GLYCERETH-8 ESTERS (UNII: C6734SM77O)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GUAR GUM (UNII: E89I1637KE)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALMOND OIL (UNII: 66YXD4DKO9)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS (UNII: R2Z4507WJN)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
OLIVE OIL (UNII: 6UYK2W1W1E)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
XANTHAN GUM (UNII: TTV12P4NEE)
SOYBEAN OIL (UNII: 241ATL177A)
PHENYLPROPANOL (UNII: 0F897O3O4M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHYTATE SODIUM (UNII: 88496G1ERL)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRAL (UNII: T7EU0O9VPP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
TOMATO (UNII: Z4KHF2C175)
ORANGE OIL (UNII: AKN3KSD11B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81475-000-01	1 in 1 BOX	09/22/2021	02/28/2022
1		50 mL in 1 JAR; 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	09/22/2021	02/28/2022

Labeler - Synergie Skin (742100650)

Revised: 9/2022

Document Id: e8959b6b-ed8c-1b8c-e053-2a95a90aa0e4

34390-5

Set id: e647457e-57d6-410e-963b-c010b9659e8b

Version: 2

Effective Time: 20220913