Label: MARY KAY FOUNDATION PRIMER- avobenzone, homosalate, octisalate and octocrylene gel
- NDC Code(s): 51531-0850-1
- Packager: Mary Kay Inc.
- 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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- Active Ingredients
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
For external use only
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
- apply liberally 15 minutes before sun exposure
- use a water-resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- 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 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- Inactive ingredients
isododecane, dimethicone/bis-isobutyl PPG-20 crosspolymer, polysilicone-11, vp/hexadecene copolymer, silica, C12-15 alkyl benzoate, polyester-7, neopentyl glycol diheptanoate, tribehenin, dipropylene glycol dibenzoate, PPG-15 stearyl ether benzoateClose
- Other information
protect this product from excessive heat and direct sunClose
- Questions or comments?
Call toll free 1-800-627-9529Close
- Principal Display Panel - 29 mL carton
1 FL. OZ. / 29 mL
- INGREDIENTS AND APPEARANCE
MARY KAY FOUNDATION PRIMER
avobenzone, homosalate, octisalate, octocrylene gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-0850 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYESTER-7 (UNII: 0841698D2F) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) TRIBEHENIN (UNII: 8OC9U7TQZ0) DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O) PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51531-0850-1 1 in 1 CARTON 1 29 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2012 Labeler - Mary Kay Inc. (103978839) Establishment Name Address ID/FEI Business Operations Mary Kay Inc. 103978839 manufacture(51531-0850)