Label: RICH GIRL HAND- avobenzone, octinoxate, and octisalate cream
- NDC Code(s): 49991-001-01, 49991-001-02
- Packager: SPECIALITY COSMETICS POLI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 14, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
- 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 value of 15 SPF 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
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Inactive ingredients
Water, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Octyldodecyl Neopentanoate, Propylene Glycol, Glyceryl Stearate, Dimethicone, PEG-100 Stearate, Glycerin, Steareth-20, Phenoxyethanol, Ceteth-20, Persea Gratissima (Avocado) Oil, Carbomer, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexylglycerin, Fragrance, O-Cymen-5-ol, Sodium Hydroxide, Butylene Glycol, Algae Extract, Centella Asiatica Extract, Echinacea Purpurea Extract, Morus Nigra Root Extract, Saxifraga Sarmentosa Extract, Scutellaria Baicalensis Root Extract, Vitis Vinifera (Grape) Fruit Extract, Disodium EDTA.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
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INGREDIENTS AND APPEARANCE
RICH GIRL HAND
avobenzone, octinoxate, and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49991-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) CETYL ALCOHOL (UNII: 936JST6JCN) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERIN (UNII: PDC6A3C0OX) STEARETH-20 (UNII: L0Q8IK9E08) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETETH-20 (UNII: I835H2IHHX) AVOCADO OIL (UNII: 6VNO72PFC1) JOJOBA OIL (UNII: 724GKU717M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) O-CYMEN-5-OL (UNII: H41B6Q1I9L) SODIUM HYDROXIDE (UNII: 55X04QC32I) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CENTELLA ASIATICA (UNII: 7M867G6T1U) ECHINACEA PURPUREA (UNII: QI7G114Y98) MORUS NIGRA ROOT (UNII: 033456LFG1) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) WINE GRAPE (UNII: 3GOV20705G) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49991-001-01 1 in 1 CARTON 05/15/2012 1 85 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49991-001-02 940 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/15/2012 Labeler - SPECIALITY COSMETICS POLI (119145240) Establishment Name Address ID/FEI Business Operations Mana Products, Inc 078870292 manufacture(49991-001)
