SERIOUSLY SOOTHING FACE CREAM- zinc oxide cream

Seriously Soothing Face Cream by

Drug Labeling and Warnings

Seriously Soothing Face Cream by is a Otc medication manufactured, distributed, or labeled by Better Planet Brands LLC, Micro Connection Enterprises, Inc., The. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc Oxide 15.50%

Purpose

Sunscreen

Uses

* Help 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 the 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.

May stain some fabrics.

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 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

INACTIVE INGREDIENT

Inactive Ingredients Water (Eau), Coconut Alkanes, Glycerin, Squalane, Cetearyl Olivate, Cetearyl Alcohol, Sorbitan Olivate, Panthenol, Tocopherol, Niacinamide, Tanacetum Annuum Flower Oil, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Argania Spinosa Kernel Oil, Sodium PCA, Allantoin, Lecithin, Bisabolol, Pullulan, Xanthan Gum, Sclerotium Gum, Caprylyl Glycol, Coco-Caprylate/Caprate, Heptyl Undecylenate, Polyhydrostearic Acid, Cetearyl Glucoside, Silica, Hexylene Glycol, Caprylhydroxamic Acid, Ethylhexylglycerin.

Questions or comments?

Call 1-877-902-2873

PRINCIPAL DISPLAY PANEL

Face cream box

Face cream tube

INGREDIENTS AND APPEARANCE

SERIOUSLY SOOTHING FACE CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54136-946
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TANACETUM ANNUUM FLOWERING TOP OIL (UNII: E2Q02N1ZC7)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
COCONUT ALKANES (UNII: 1E5KJY107T)
PANTHENOL (UNII: WV9CM0O67Z)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TOCOPHEROL (UNII: R0ZB2556P8)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
ALLANTOIN (UNII: 344S277G0Z)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
PULLULAN (UNII: 8ZQ0AYU1TT)
SQUALANE (UNII: GW89575KF9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN OLIVATE (UNII: MDL271E3GR)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ARGAN OIL (UNII: 4V59G5UW9X)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
COCONUT OIL (UNII: Q9L0O73W7L)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54136-946-19	1 in 1 CARTON	04/22/2020
1		52 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	04/22/2020

Labeler - Better Planet Brands LLC (960253719)

Establishment
Name	Address	ID/FEI	Business Operations
Micro Connection Enterprises, Inc., The		144297160	manufacture(54136-946)