Bio-Suisse BB Skin-Perfecting Mineral Beauty Balm Broad Spectrum SPF 20

Skin-Perfecting Mineral Beauty Balm Broad Spectrum SPF 20 by

Drug Labeling and Warnings

Skin-Perfecting Mineral Beauty Balm Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by Luzern Laboratories, Inc, Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKIN-PERFECTING MINERAL BEAUTY BALM BROAD SPECTRUM SPF 20- titanium dioxide, zinc oxide cream 
Luzern Laboratories, Inc

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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Bio-Suisse BB Skin-Perfecting Mineral Beauty Balm
Broad Spectrum SPF 20

Active ingredients

Titanium Dioxide (CI 77891) 3.0%
Zinc Oxide (CI 77947) 7.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner.

Keep out of reach of children.

Consult a health care practitioner prior to use on children less than six months of age.

Directions

Shake well before each application. Apply liberally before sun exposure. Reapply every 2 hours of sun exposure, or after swimming, excessive perspiration, or towel drying.

INACTIVE INGREDIENTS:

WATER (AQUA*†), CYCLOMETHICONE†, CAPRYLIC/CAPRIC TRIGLYCERIDE*†, OCTYLDODECYL NEOPENTANOATE†, PROPANEDIOL*†, ALGAE EXTRACT*†, METHYLCELLULOSE*†, ETHYLHEXYL ISONONANOATE†, DIMETHICONE, STEARETH-21, HEXYLDECANOL*†, CETYL ALCOHOL*†, GLYCERIN**†, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT**†, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT**†, SODIUM ASCORBYL PHOSPHATE*†, SODIUM HYALURONATE*†, PANTHENOL*†, SODIUM PCA*†, TOCOPHERYL ACETATE*†, TOCOPHERSOLAN†, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT**†, BUDDLEJA DAVIDII EXTRACT**†, LEONTOPDOIUM ALPINUM (EDELWEISS) EXTRACT**†, THYMUS VULGARIS (THYME) EXTRACT**†, C14-22 ALCOHOLS*†, ISOSTEARYL PALMITATE*†, STEARETH-2, C12-20 ALKYL GLUCOSIDE*†, L-ARGININE*†, CARBOMER†, CUCUMIS SATIVUS (CUCUMBER) OIL**†, CITRIC ACID*†, TETRASODIUM GLUTAMATE DIACETATE*†, CAPRYLHYDROXAMIC ACID*†, GLYCERYL CAPRYLATE*†, ETHYLHEXYLGLYCERIN*†, GLYCERYL UNDECYL

*NATURAL-DERIVED / DÉRIVÉS DE NATUREL AND/OR ECOCERT
**CERTIFIED ORGANIC/CERTIFIÉ ORGANIQUE USDA/ECOCERT/BIO-SUISSE
† ENVIRONMENTAL WORKING GROUP (EWG) LOW HAZARD RATING OF “GREEN 0 – 2” (NON-TOXIC, NON-IRRITATING)

Principal Display Panel - Carton Label

BIO-SUISSE BB

SKIN-PERFECTING
MINERAL BEAUTY BALM
BROAD SPECTRUM SPF 20

PERFECTEUR DE TEINT CRÈME
MINÉRALE BB ÉCRAN SOLAIRE SPF 20

LUZERN®
LABORATORIES

ALL SKIN TYPES TOUS TYPES DE PEAU

1.7 FL OZ / 50 ml

Carton Label.jpg
SKIN-PERFECTING MINERAL BEAUTY BALM BROAD SPECTRUM SPF 20 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63127-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PROPANEDIOL (UNII: 5965N8W85T)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARETH-21 (UNII: 53J3F32P58)  
HEXYLDECANOL (UNII: 151Z7P1317)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHERSOLAN (UNII: O03S90U1F2)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GINGER (UNII: C5529G5JPQ)  
BUDDLEJA DAVIDII LEAF (UNII: X380815D32)  
LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I)  
THYME (UNII: CW657OBU4N)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
STEARETH-2 (UNII: V56DFE46J5)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
ARGININE (UNII: 94ZLA3W45F)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63127-200-011 in 1 CARTON03/13/201402/29/2020
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/13/201402/29/2020
Labeler - Luzern Laboratories, Inc (188040476)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing, Inc.793406000MANUFACTURE(63127-200)

Revised: 12/2019
 
Luzern Laboratories, Inc