OTC Medication Information: BB Cream Broad Spectrum SPF 25 Light 01

BB CREAM BROAD SPECTRUM SPF 25 LIGHT 01- zinc oxide cream
Allure Labs 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.

Active Ingredients:

Zinc Oxide 21.0%

Purpose: Sunscreen

Uses:

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warning: For external use only.

Do not use: on damaged or broken skin.

When using this products:

  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Apply generously 15 minutes before sun exposer.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating. Immediatly after towel drying. at least every 2 hours.
  • Sun protection measures. Spending time in the sun increase 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 10 a.m. — 2 p.m.
  • Wear long sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor.

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients: Water (Aqua), Caprylyc/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Glyceryl Stearate, PEG-100 Stearate, Coco-Glucoside, Helianthus Annus, Caprylyl/Capryl Glucoside, Sclerotium Gum, Xanthan Gum, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Pyrus Malus (Apple) Fruit Extract, Cetearyl Glucoside, Tetrahexyldecyl Ascorbate, Butyrospermum Parkii (Shea) Butter, Coco-Caprylate/Caprate, Tocopherol, Sodium Hyaluronate, Phenoxyethanol, Ethylhexylglycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth 7, Hydrolyzed Jojoba Esters, Citric Acid, Anthemis Nobilis Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Extract, Triethoxycaprylylsilane, Dimethicone, Fragrance, Limonene, Linalool, May contain +/-, Mica (Cl 77019), Titanium Dioxide (Cl 77891), Iron Oxides (Cl77491, Cl77492, Cl 77499).

FLOETIC BEAUTY LLC, DIST.

CLYDE HILL, WA 98004

MADE IN USA

WWW.FLOETICBEAUTY.COM

BB Cream BS SPF 25 Light 01
(click image for full-size original)
BB CREAM BROAD SPECTRUM SPF 25 LIGHT 01
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4178
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 210 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
MEDIUM-CHAIN TRIGLYCERIDES
COCONUT ALKANES
CETOSTEARYL ALCOHOL
GLYCERIN
ALOE VERA LEAF
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
COCO GLUCOSIDE
SUNFLOWER OIL
PHYTATE SODIUM
ALCOHOL
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE
BETASIZOFIRAN
XANTHAN GUM
POLYHYDROXYSTEARIC ACID (2300 MW)
POLYGLYCERYL-3 RICINOLEATE
ISOSTEARIC ACID
LECITHIN, SOYBEAN
APPLE
CETEARYL GLUCOSIDE
TETRAHEXYLDECYL ASCORBATE
SHEA BUTTER
COCO-CAPRYLATE/CAPRATE
TOCOPHEROL
HYALURONATE SODIUM
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
POLYACRYLAMIDE (10000 MW)
C13-14 ISOPARAFFIN
LAURETH-7
HYDROLYZED JOJOBA ESTERS (ACID FORM)
CITRIC ACID MONOHYDRATE
CHAMAEMELUM NOBILE FLOWER
CALENDULA OFFICINALIS FLOWER
GREEN TEA LEAF
TRIETHOXYCAPRYLYLSILANE
DIMETHICONE
LIMONENE, (+)-
LINALOOL, (+/-)-
MICA
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62742-4178-2 1 BOTTLE in 1 CARTON contains a BOTTLE (62742-4178-1)
1 NDC:62742-4178-1 20 mL in 1 BOTTLE This package is contained within the CARTON (62742-4178-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 11/21/2019
Labeler — Allure Labs Inc (926831603)

Revised: 11/2019 Allure Labs Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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