FACE STOCKHOLM BB NATURAL BEAUTY BALM SPF 30 SHADE NR 2- octinoxate, titanium dioxide, zinc dioxide cream
Face Stockholm

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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Face Stockholm BB Natural Beauty Balm SPF 30 Sunscreen

Active Ingredients

Ethylhexyl methoxycinnamate 2.00%

Titanium dioxide 12.80%

Zinc oxide 4.90%

Purpose

UV Filter

Uses

helps prevent sunburn

Warnings

For external use only.

Skin cancer/skin aging alert spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

When using this product

keep out of eyes

rinse with water to remove

use this product on the face

do not use on damaged or broken skin

Stop use and ask a doctor if

a 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 and as needed

use a water resistant sunscreen if swimming or sweating

children under 6 months; ask a doctor

Other information

protect this product from excessive heat and direct sun

Inactive Ingredients

ALUMINUM STARCH OCTENYLSUCCINATE, OCTYLDODECANOL, HYDROGENATED

POLYDECENE, CETEARYL ETHYLHEXANOATE, POLYETHYLENE, BIS-DIGLYCERYLPOLYACYLADIPATE-2, TRIMETHYL- SILOXYPHENYL DIMETHICONE, MICROCRYSTALLINE WAX, POLYSORBATE 20, SORBITAN SESQUIOLEATE, STEARIC ACID, ALUMINUM HYDROXYDE, MICA, TRIETHOXYCAPRYLYLSILANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHERYL ACETATE, UBIQUINONE, SQUALANE, ORYZANOL, SPILANTHES ACMELLA FLOWER EXTRACT, PENTAERYTHRITYL TETRA-DI-T-BUTYL YDROXYHYDROCINNAMATE, ASCORBYL TETRAISOPALMITATE, TITANIUM DIOXIDE, IRON OXIDES.

Questions & Comments?

Call us at 1.800.334.FACE

Product Labeling

image description

FACE STOCKHOLM BB NATURAL BEAUTY BALM SPF 30 SHADE NR 2
octinoxate, titanium dioxide, zinc dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58494-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	128 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	49 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
OCTYLDODECANOL (UNII: 461N1O614Y)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MICA (UNII: V8A1AW0880)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UBIQUINONE Q2 (UNII: I7T5V2W47R)
SQUALANE (UNII: GW89575KF9)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58494-002-75	1 in 1 BOX	07/25/2016	04/01/2019
1		7.5 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/25/2016	04/01/2019

Labeler - Face Stockholm (877458596)

Registrant - B. Kolormakeup & Skincare SPA (439270534)

Name	Address	ID/FEI	Business Operations
Establishment
B. Kolormakeup & Skincare SPA		435581360	repack(58494-002) , relabel(58494-002)

Name	Address	ID/FEI	Business Operations
Establishment
B. Kolormakeup & Skincare SPA		439270534	manufacture(58494-002)

Revised: 10/2019

Document Id: 95f94d59-1a84-32ff-e053-2995a90a290b

Set id: 6cbec1a0-3608-48f3-8fce-b8ae088260dc

Version: 7

Effective Time: 20191028

Face Stockholm