SUPER BB BEAUTY BALM CREAM SPF 30- titanium dioxide, zinc oxide cream

Super BB Beauty Balm Cream by

Drug Labeling and Warnings

Super BB Beauty Balm Cream by is a Otc medication manufactured, distributed, or labeled by LINA GALE, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 5.76%

Zinc Oxide 2.94%

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 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

children under 6 months of age: Ask a doctor

use a water resistant sunscreen if swimming or sweating

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, hats, and sunglasses

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water/Eau, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Neopentyl Glycol Diheptanoate, Dimethicone, Butylene Glycol, Bis-PEG/PPG-14/14 Dimethicone, Cetearyl Alcohol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, PEG-10 Dimethicone, Sodium Chloride, Glycerin, Calcium Aluminum Borosilicate, Salix Alba (Willow) Bark Extract, Butyrospermum Parkii (Shea) Butter, Perilla Ocymoides Seed Oil, Lysolecithin, Polysilicone-11, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Castor Oil Phosphate, Disodium EDTA, Disteardimonium Hectorite, Glyceryl Stearate SE, Laureth-12, Mica, PEG/PPG-18/18 Dimethicone, Polysorbate 60, Propylene Carbonate, Sodium Hydroxide, Triethoxycaprylylsilane, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol. May Contain/Peut Contenir: Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

Questions or comments?

Call toll free 1-800-227-0333

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INGREDIENTS AND APPEARANCE

SUPER BB BEAUTY BALM CREAM  SPF 30
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69514-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	57.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
SALIX ALBA BARK (UNII: 205MXS71H7)
SHEA BUTTER (UNII: K49155WL9Y)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURETH-12 (UNII: OAH19558U1)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69514-124-02	1 in 1 BOX	01/01/2014
1	NDC: 69514-124-01	35 mL 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	01/01/2014

Labeler - LINA GALE, INC (078890119)