Label: ANDALOU BB UNTINTED WITH SPF-30- zinc oxide lotion
- NDC Code(s): 55560-0101-1
- Packager: Andalou naturals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active Ingredient
Zinc Oxide 20%Close
- Daily, alone or under make-up.
- Apply liberally 15 minutes before sun exposure and as needed.
- Reapply at least every 2 hours.
- 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.
- Inactive Ingredients
Aloe Barbadensis Juice1, Simmondsia Chinensis (Jojoba) and Helianthus Annuus (Sunflower) Oils1, Sorbitan Stearate, Glyceryl Stearate, Fruit Stem Cell and BioActive 8 Berry Complex1, Caprylic/Capric Triglycerides, Hyaluronic Acid, Salvia Officinalis (Sage), Serenoa Rapens (Saw Palmetto) and Salix Alba (Willow Bark) Extracts1, Punica Granatum (Pomegranate) Oil1, Magnesium Ascorbyl Phosphate (Vitamin C), Algae Extract, Zinc Gluconate, Magnesium Sulfate, Aspalathus Linearis (Rooibos), Hibiscus Rosa-Sinensis and Camellia Sinensis (White Tea) Extracts12, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) and Cymbopogon Martini (Palmarosa) Oils1
- Other Information
- Protect the product in this container from excessive heat and direct sun.
Call (888) 898-6955 or visit www.Andalou.comClose
- PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton
FRUIT STEM CELL SCIENCE
with SPF 30
FRUIT STEM CELLS
FRUIT STEM CELLS
RENEW ■ REPAIR ■ REGENERATE
58 mL e 2 fl oz
- INGREDIENTS AND APPEARANCE
ANDALOU BB UNTINTED WITH SPF-30
zinc oxide lotion
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55560-0101 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (Zinc Oxide) Zinc Oxide 20 g in 100 mL Inactive Ingredients Ingredient Name Strength glyceryl monostearate sage saw palmetto willow bark pomegranate seed oil aloe vera leaf zinc gluconate medium-chain triglycerides sorbitan monostearate mandarin oil magnesium sulfate helianthus annuus flowering top jojoba oil tocopherol magnesium ascorbyl phosphate hyaluronate sodium palmarosa oil phenylethyl alcohol ethylhexylglycerin Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55560-0101-1 58 mL in 1 TUBE 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)