Label: VITAMIN C BB BEAUTY BALM SHEER TINT SFP 30- zinc oxide lotion
- NDC Code(s): 55560-0108-1
- Packager: Andalou naturals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 17, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
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Directions
- Daily, alone or under make-up.
- Apply liberally 15 minutes before sun exposure and as needed.
- Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
- Use 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses.
- Children under 6 months: ask a doctor.
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Non Medicinal Ingredients
Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Caprylic/Capric Triglycerides, Vegetable Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil1, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil1, Punica Granatum (Pomegranate) Seed Oil1, Hydrogenated Castor Oil, Dimethicone, Magnesium Sulfate, Sorbitan Sesquioleate, Fruit Stem Cells (Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Sodium Hyaluronate, Magnesium Ascorbyl Phosphate (Vitamin C), Borago Officinalis (Borage) Seed Oil1, Cucumis Sativus (Cucumber) Fruit Extract1, Zea Mays (Corn) Starch1, Camellia Sinensis (White Tea) Leaf Extract12, Hibiscus Sabdariffa Flower Extract12, Tocopherol, Iron Oxides, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil1
- Other Information
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton
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INGREDIENTS AND APPEARANCE
VITAMIN C BB BEAUTY BALM SHEER TINT SFP 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55560-0108 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) JOJOBA OIL (UNII: 724GKU717M) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) SUNFLOWER OIL (UNII: 3W1JG795YI) POMEGRANATE SEED OIL (UNII: 0UI45XV0T6) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) APPLE (UNII: B423VGH5S9) VITIS VINIFERA SEED (UNII: C34U15ICXA) ACAI (UNII: 46AM2VJ0AW) ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ) ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU) EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) HYALURONATE SODIUM (UNII: YSE9PPT4TH) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) BORAGE SEED OIL (UNII: F8XAG1755S) CUCUMBER (UNII: YY7C30VXJT) STARCH, CORN (UNII: O8232NY3SJ) WHITE TEA (UNII: O0M3396E09) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MANDARIN OIL (UNII: NJO720F72R) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55560-0108-1 1 in 1 CARTON 12/10/2012 1 58 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 FINAL part352 12/10/2012 Labeler - Andalou naturals (011472720) Establishment Name Address ID/FEI Business Operations Sun Deep Inc 189788201 MANUFACTURE(55560-0108)