Label: SUPER BB BEAUTY BALM CREAM SPF 30- titanium dioxide, zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 31645-208-01, 31645-208-02 - Packager: PHYSICIANS FORMULA INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 28, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
-
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
-
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?
- Principle Display Panel
-
INGREDIENTS AND APPEARANCE
SUPER BB BEAUTY BALM CREAM SPF 30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:31645-208 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 BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:31645-208-02 1 in 1 BOX 11/15/2016 1 NDC:31645-208-01 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 01/05/2013 Labeler - PHYSICIANS FORMULA INC (021261805)
