NDC | 42508-079-08, 42508-079-11 |
Set ID | 1800d39c-ca3b-484c-9dab-5af30cd25045 |
Category | HUMAN OTC DRUG LABEL |
Packager | Arbonne International, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
Uses
- 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
- Warnings
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a 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 value 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-sleeved shirts, pants, hats, and sunglasses
- children under 6 months of age: ask a doctor
- Other information
-
Inactive ingredients
water, C12-15 alkyl benzoate, glycerin, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3 methylglucose distearate, cetyl alcohol, caprylic/capric triglyceride, cetyl dimethicone, cetyl palmitate, dimethicone, behenyl alcohol, cetearyl alcohol, glyceryl stearate, squalane, isononyl isononanoate, butyrospermum parkii (shea) butter, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, xanthan gum, caprylyl glycol, sodium lauroyl glutamate, stearic acid, polysorbate 60, sorbitan isostearate, olea europaea (olive) fruit oil, hippophae rhamnoides oil, aloe barbadensis leaf juice, osmanthus fragrans flower extract, paeonia albiflora root extract, chondrus crispus extract, laminaria digitata extract, ganoderma lucidum (mushroom) stem extract, serenoa serrulata fruit extract, anthemis nobilis flower extract, cucumis sativus (cucumber) fruit extract, trifolium pratense (clover) flower extract, undaria pinnatifida extract, lithothamnion calcareum extract, tetrahexyldecyl ascorbate, panthenol, tocopheryl acetate, pantolactone, acetyl tetrapeptide-2, vinyl dimethicone/methicone silsesquioxane crosspolymer, micrococcus lysate, biosaccharide gum-1, disodium acetyl glucosamine phosphate, ethylhexylglycerin, citric acid, caprylhydroxamic acid, phytic acid, sodium citrate, sodium phosphate, disodium phosphate, aminomethyl propanediol, propanediol, triethoxycaprylylsilane, chlorphenesin, phenoxyethanol.
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 g Jar Carton
-
INGREDIENTS AND APPEARANCE
RE9 ADVANCED LIFTING AND CONTOURING BROAD SPECTRUM SPF 15 SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42508-079 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.45 g in 100 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Aminomethyl Propanediol (UNII: CZ7BU4QZJZ) Chamaemelum Nobile Flower (UNII: O2T154T6OG) Docosanol (UNII: 9G1OE216XY) Biosaccharide Gum-1 (UNII: BB4PU4V09H) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Caprylhydroxamic Acid (UNII: UPY805K99W) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Caprylyl Glycol (UNII: 00YIU5438U) Cetostearyl Alcohol (UNII: 2DMT128M1S) Cetyl Alcohol (UNII: 936JST6JCN) Cetyl Dimethicone 25 (UNII: U4AS1BW4ZB) Cetyl Palmitate (UNII: 5ZA2S6B08X) Chlorphenesin (UNII: I670DAL4SZ) Chondrus Crispus (UNII: OQS23HUA1X) Citric Acid Monohydrate (UNII: 2968PHW8QP) Cucumber (UNII: YY7C30VXJT) Dimethicone (UNII: 92RU3N3Y1O) Ethylhexylglycerin (UNII: 147D247K3P) Ganoderma Lucidum Stem (UNII: U8PA41532G) Glycerin (UNII: PDC6A3C0OX) Glyceryl Monostearate (UNII: 230OU9XXE4) Glyoxal (UNII: 50NP6JJ975) Hippophae Rhamnoides Seed Oil (UNII: T53SBG6741) Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.S At 1.5%) (UNII: 86FQE96TZ4) Isononyl Isononanoate (UNII: S4V5BS6GCX) Laminaria Digitata (UNII: 15E7C67EE8) Olive Oil (UNII: 6UYK2W1W1E) Osmanthus Fragrans Flower (UNII: 4VA0BH57HU) Paeonia Lactiflora Root (UNII: 3Z3866YW6P) Dexpanthenol (UNII: 1O6C93RI7Z) Pantolactone, (R)- (UNII: J288D7O0JS) Phenoxyethanol (UNII: HIE492ZZ3T) Fytic Acid (UNII: 7IGF0S7R8I) Polysorbate 60 (UNII: CAL22UVI4M) Propanediol (UNII: 5965N8W85T) Saw Palmetto (UNII: J7WWH9M8QS) Jojoba Oil (UNII: 724GKU717M) Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR) Sodium Lauroyl Glutamate (UNII: NCX1UU2D33) Sorbitan Isostearate (UNII: 01S2G2C1E4) Squalane (UNII: GW89575KF9) Stearic Acid (UNII: 4ELV7Z65AP) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Triethoxycaprylylsilane (UNII: LDC331P08E) Trifolium Pratense Flower (UNII: 4JS0838828) Undaria Pinnatifida (UNII: ICV1OK7M1S) Water (UNII: 059QF0KO0R) Xanthan Gum (UNII: TTV12P4NEE) POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE) SHEA BUTTER (UNII: K49155WL9Y) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK) ACETYL TETRAPEPTIDE-2 (UNII: M24S4WZS8J) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) DISODIUM ACETYL GLUCOSAMINE PHOSPHATE (UNII: SC89MF712W) SODIUM PHOSPHATE (UNII: SE337SVY37) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42508-079-08 1 in 1 CARTON 05/10/2018 1 50 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:42508-079-11 3 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2015 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/01/2015 Labeler - Arbonne International, LLC (021541164)