Label: SMOOTHING MINERAL PRIMER SPF-15- titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69863-101-11, 69863-101-12, 69863-101-13, 69863-101-51 - Packager: HATCHBEAUTY PRODUCTS LLC
- 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 December 16, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USE
- WARNINGS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
Directions
• Apply generously to face 15 minutes before sun exposure.
• Children under 6 months of age: ask a doctor.
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.
• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating; immediately after towel drying
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INACTIVE INGREDIENTS
Cyclopentasiloxane, Isododecane, Glyceryl Behenate, PEG-10 Dimethicone, Polysilicone-11, Alumina, Water, Methicone, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Prunus Persica (Peach) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Oenothera Biennis (Evening Primrose) Root Extract, Jasminum Officinale (Jasmine) Extract, Amaranthus Caudatus Seed Extract, Ethylhexylglycerin, Phenoxyethanol.
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SMOOTHING MINERAL PRIMER SPF-15
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69863-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.90 g in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISODODECANE (UNII: A8289P68Y2) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYSILICONE-15 (UNII: F8DRP5BB29) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) METHICONE (20 CST) (UNII: 6777U11MKT) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEACH (UNII: 3OKE88I3QG) VITIS VINIFERA SEED (UNII: C34U15ICXA) OENOTHERA BIENNIS ROOT (UNII: SL194W0S0F) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) AMARANTHUS CAUDATUS SEED (UNII: FJ722PPQ9M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69863-101-51 1 in 1 BOX 1 NDC:69863-101-11 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:69863-101-12 5 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:69863-101-13 7 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 06/18/2015 Labeler - HATCHBEAUTY PRODUCTS LLC (044612361) Registrant - HATCHBEAUTY PRODUCTS LLC (044612361)
